Written and maintained by CASRAI Editorial Board
Last updated
General product information, not medical advice and not a procedure guide. Facts below come from the cited regulator, supply-catalogue and manufacturer records, checked 2026-10-30.
Short answer
An Army-Navy retractor is a hand-held, double-ended surgical retractor: with a fenestrated handle and a 90-degree angled set of two blades. It is a reusable manual instrument; the Miltex record lists it as supplied non-sterile and requiring steam sterilisation. In U.S. records the same instrument can appear under more than one FDA product code, which is why listings disagree.
Definition and scope
A retractor is a surgical instrument used to hold back underlying organs and tissues (UNFPA Global Supply product page). The Army-Navy pattern is described there as a double-ended instrument with a fenestrated handle and a 90-degree angled set of two blades, and its instructions for use list retracting skin, fatty tissue and muscle in superficial surgery. The AccessGUDID device description for the Miltex version calls this type of device a hand-held, non-self-retaining retractor.
Catalogues use several names for it: “Army-Navy”, “U.S. Army” and “US Army/Navy” all appear in FDA device listings, and it is sold as a set of 2. This page covers the manual instrument only. For the wider family, see what a surgical retractor is; for the blade geometry that distinguishes retractor patterns, see retractor blades.
How the instrument is built and reprocessed
The UNFPA record gives one concrete specification: overall length 215 mm, tip length 45.5 mm, width 15 mm, right-angled, reusable. Its instructions for use state that the item is cleaned, disinfected after each use and sterilised in a steam steriliser.
The AccessGUDID record for an Integra Miltex U.S. Army Retractor, 8-1/2″, double-ended, set of 2 agrees on the practical points: it is not packaged sterile, it requires sterilisation before use (moist heat or steam), it is not single-use, and its labelling carries no MRI safety information. For how sterilisation methods are validated in general, see sterilization validation.
Variants in published records
The table lists only values printed in the cited records. It shows how much naming and dimensions vary between labelers, so a specification line should be read against the exact record.
| Record | Name as listed | Dimensions or features as listed |
|---|---|---|
| UNFPA Global Supply | Army Navy retractors, double-ended | 215 mm overall, 45.5 mm tip, 15 mm wide, reusable |
| AccessGUDID (Integra Miltex) | U.S. Army Retractor, double-ended, set of 2 | 8-1/2″; supplied non-sterile; steam sterilisation required |
| openFDA UDI (ELMED) | US Army / Navy insulated retractor set of 2 | 8 1/2″ overall length; insulated variant |
| openFDA UDI (Avalign) | Custom Army Navy retractors, narrow tapered ends, set of 2 | Short side 9 mm, long side 10 mm |
| openFDA UDI (Surgical Direct) | 8 1/4″ Army Navy retractor, titanium | 8 1/4″; titanium; coded FGN |
Regulatory classification and product codes
In the openFDA classification database, the general code GAD, “Retractor”, is Class I under 21 CFR 878.4800, which covers manual surgical instruments for general use: nonpowered, hand-held or hand-manipulated devices, reusable or disposable, used in various general surgical procedures. That regulation classifies them as Class I (general controls) and exempts them from premarket notification, subject to the limitations in 21 CFR 878.9 (read via Cornell LII).
Specialty retractor codes sit under other regulations. FGN, “Retractor, Non-Self-Retaining”, is Class I under 21 CFR 876.4730 (gastroenterology and urology). GZT, “Retractor, Self-Retaining, For Neurosurgery”, is Class II under 21 CFR 882.4800. The openFDA UDI data show the Surgical Direct titanium Army Navy retractor under FGN while the Miltex, ELMED and Avalign listings carry GAD, so the same pattern of instrument can carry different codes depending on the labeler’s choice.
Reading a listing: set of 2, product codes and related patterns
- Set of 2: several listings describe the item as a set of 2, so a line item can mean one set rather than one instrument.
- Product code: a classification lookup that searches only GAD will miss records filed under FGN.
- Reprocessing: the records above describe a reusable instrument supplied non-sterile; it sits alongside other reusable instruments in a surgical pack.
- Related patterns: self-retaining designs such as the Balfour retractor or the Gelpi retractor are different instruments.
Common misunderstandings
- “Army-Navy” and “U.S. Army” are always different instruments. The records above use both names for double-ended retractors of this kind; confirm dimensions in the specific listing.
- Every listing has the same size. Published lengths range from 215 mm to 8 1/2″, and a narrow tapered variant lists 9 mm and 10 mm ends.
- It is a Class II device. The general-use code GAD is Class I; Class II appears for the neurosurgical self-retaining code GZT.
- It is self-retaining. The AccessGUDID description of the Miltex version is a non-self-retaining retractor, held by hand, unlike the self-retaining designs above.
FAQ
What is an Army-Navy retractor used for?
The UNFPA product text lists retracting skin, fatty tissue and muscle during superficial surgery. This page covers the instrument only and gives no procedure instructions.
Is an Army-Navy retractor sterile when supplied?
The AccessGUDID record for the Miltex version says it is not packaged sterile and requires sterilisation (moist heat or steam) before use. Check the labeler’s own instructions for use for any other model.
What FDA class is it?
Under product code GAD it is Class I (21 CFR 878.4800). A titanium listing is filed under FGN, also Class I (21 CFR 876.4730).
Is an Army-Navy retractor self-retaining?
No. The AccessGUDID description of the Miltex version is a hand-held, non-self-retaining retractor, and the openFDA code FGN is titled “Retractor, Non-Self-Retaining”.
Is it reusable?
Yes. UNFPA lists it as reusable and AccessGUDID records it as not single-use.
Sources
All sources checked 2026-10-30.
- openFDA device classification API: https://api.fda.gov/device/classification.json?search=device_name:retractor
- openFDA UDI API: https://api.fda.gov/device/udi.json?search=army+navy
- 21 CFR 878.4800: https://www.law.cornell.edu/cfr/text/21/878.4800
- AccessGUDID record 10381780439585: https://accessgudid.nlm.nih.gov/devices/10381780439585
- UNFPA Global Supply, Army Navy retractors, double-ended: https://globalsupply.unfpa.org/products/army-navy-retractors-double-ended-for-subumbilical-procedure-1002013.html
