Written and maintained by CASRAI Editorial Board
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General product and regulatory information only. This page is not medical advice and does not describe surgical technique.
Short answer
“Bookwalter” is a brand name, Symmetry Bookwalter, from Aspen Surgical Products, Inc., for a family of reusable self-retaining retractor components, including blades. In the FDA device database the blades are filed under product code GAD (Retractor), Class 1. The records for them list the devices as reusable, supplied non-sterile, and requiring steam sterilization before use.
Definition and scope
A surgical retractor holds the edges of an incision apart. A self-retaining retractor stays in position without a person holding it. For the general concept, see what a surgical retractor is. This page covers only what public regulatory and device records say about the Bookwalter name and the blades listed under it, so that supply and sterile-processing staff can read a catalogue entry correctly.
The National Library of Medicine AccessGUDID database lists the brand as “Symmetry Bookwalter” with the company Aspen Surgical Products, Inc. Its record for a malleable blade describes it as a Bookwalter malleable retractor blade, 2 in blade width x 4.5 in blade depth (record DI 00887482193174).
How the records describe the device
The GUDID record for a Balfour-style blade (catalog number BW1271017, 3 1/2 in x 2 3/4 in, 89 mm x 70 mm) carries GMDN term 46774, “Surgical retractor/retraction system blade, reusable”. GMDN defines it as designed to function as a parting edge to separate the margins of a wound or incision during a surgical procedure. The record gives:
- Single-use: No (reusable).
- Device packaged as sterile: No.
- Requires sterilization prior to use: Yes, method listed as moist heat or steam sterilization.
- MRI safety: the labeling does not contain MRI safety information.
The malleable-blade record lists the same reusable, non-sterile, steam-sterilization attributes. Both records are in the NLM AccessGUDID database (checked 2026-10-30).
Types and related concepts
| Item in the records | What the source says | Source |
|---|---|---|
| Malleable blade, 2 in x 4.5 in | Listed under the Symmetry Bookwalter brand; product code GAD; reusable | AccessGUDID DI 00887482193174 |
| Balfour-style blade, 3 1/2 in x 2 3/4 in | Listed under Symmetry Bookwalter Balfour; product code GAD; reusable | AccessGUDID DI 00887482033869 |
| Product code GAD “Retractor” | Class 1; 21 CFR 878.4800; panel General, Plastic Surgery | openFDA device classification |
| Product code FFO “Retractor, self-retaining” | Class 1; 21 CFR 876.4730; panel Gastroenterology, Urology; exempt from premarket notification, subject to the limitations in 21 CFR 876.9 | openFDA classification; 21 CFR 876.4730 |
The Balfour-style row shows why the two names are confused. A Balfour-style blade appears as a component sold within the Bookwalter brand. For the standalone Balfour retractor, see the Balfour retractor guide; for blade vocabulary, see retractor blades.
Where it matters for labs, clinics and supply decisions
A catalogue-reading checklist drawn only from the records above:
- Brand versus type. The GUDID brand field is “Symmetry Bookwalter”. The brand, company and catalog number fields identify the actual product.
- Reusable. Both records say not single-use.
- Not supplied sterile. Both records say the device is not packaged sterile and requires sterilization before use, with steam listed.
- Dimensions in the description. Blade width and depth appear in the device description (for example 2 in x 4.5 in), so compare them as written.
- Classification codes. Blades appear under GAD in these records. A self-retaining retractor listing under another code such as FFO is a separate classification; read the product’s own record.
- MRI statement. The records state that the labeling has no MRI safety information.
Related instruments: the Gelpi retractor and the rib spreader.
Common misunderstandings
- “Bookwalter is a generic instrument type.” In the database it is a brand name (Symmetry Bookwalter).
- “Bookwalter and Balfour are alternatives.” One record lists a Balfour-style blade within the Bookwalter brand.
- “Class 1 means no processing requirements.” The class describes regulatory controls; the records separately state that the blades require steam sterilization before use.
FAQ
Is a Bookwalter retractor reusable?
The AccessGUDID records for the malleable blade and the Balfour-style blade list the blades as reusable (single-use: No).
Does it come sterile?
No. The records say the device is not packaged sterile and requires sterilization before use, with moist heat or steam sterilization listed.
Is Bookwalter a brand name?
The GUDID brand field reads “Symmetry Bookwalter” with company Aspen Surgical Products, Inc.
What FDA class is it?
The blades are filed under product code GAD, Retractor, which openFDA lists as Class 1 under 21 CFR 878.4800.
Sources
- NLM AccessGUDID, DI 00887482193174, https://accessgudid.nlm.nih.gov/devices/00887482193174 (checked 2026-10-30)
- NLM AccessGUDID, DI 00887482033869, https://accessgudid.nlm.nih.gov/devices/00887482033869 (checked 2026-10-30)
- FDA openFDA device classification, product codes GAD and FFO, https://api.fda.gov/device/classification.json (data updated 2026-10-19, checked 2026-10-30)
- 21 CFR 876.4730, https://www.law.cornell.edu/cfr/text/21/876.4730 (checked 2026-10-30)
