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Nasal Splint: Types, Materials and How Internal and External Splints Differ

A reference to nasal splints: external vs internal (Doyle-style) types, materials, catalog sizes, sterility and the regulatory entries that apply, from the eCFR, IFUs and FDA records.

Written and maintained by CASRAI Editorial Board

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This page describes products and general use; it is not medical advice.

A nasal splint is a thin, rigid or flexible device placed against the nose to support or immobilize it (see also What Is a Splint? for splints in general). Two different product families share the name: external splints that sit on the outside of the nose, and internal (intranasal) splints that sit against the nasal septum inside it, including the Doyle-style splints used after septal surgery. Who uses them: ENT surgeons and clinic staff, the buyers who stock them, and students learning the device categories.

What a nasal splint is

The US regulation for the external type, 21 CFR 874.5800, defines an external nasal splint as "a rigid or partially rigid device" intended for external use to immobilize parts of the nose. It is a Class I medical device under general controls and is exempt from premarket notification, subject to the limitations in 21 CFR 874.9.

Internal septal splints are listed in FDA’s AccessGUDID under the product code LYA, "SPLINT, INTRANASAL SEPTAL". A manufacturer instruction sheet for non-sterile internal splints (Summit Medical) gives the indication as temporary, post-surgical splinting of the nasal septum where that is desired.

How internal and external splints are built

The Summit Medical instructions for use (IFU) describe its internal splints as made of silicone, designed for the splinting needs that follow various nasal surgical procedures. That IFU is one manufacturer’s document and does not describe every splint. Medtronic’s ENT catalog shows other constructions: fluoroplastic (its Simple splint) and thermoplastic (its Thermasplints).

Types and variants

Type Typical use (as the source describes it) Key difference Source
External nasal splint Immobilization of parts of the nose, used on the outside Class I, 510(k)-exempt under 21 CFR 874.5800 eCFR; Medtronic lists external splints in packs of 5 and 25
Doyle bi-valve septal splint Listed by Medtronic as a post-operative ENT splint (1 pair per pack) Two-part (bi-valve) septal design per the product name Medtronic catalog
Doyle II intranasal airway splint Listed by Medtronic as an intranasal airway splint; the GUDID record for the Doyle II airway set shows product code LYA Supplied sterile and single use; no sterilization needed before use, per GUDID Medtronic catalog; AccessGUDID
Merocel silicone splint Structural support and stabilization after septal and nasal surgery Silicone, 1.0 mm thickness Medtronic catalog
Reuter splint Internal splint offered in several configurations Regular or large; slit or no slit; thin (0.25 mm) or thick (0.5 mm) Medtronic catalog
Simple splint Internal splint, fluoroplastic 70 mm x 44 mm, 0.50 mm thick Medtronic catalog
Thermasplint Thermoplastic splint Small, medium or large Medtronic catalog

Sizes and specifications that matter

The sizes below are the catalog values Medtronic publishes; other manufacturers list their own. Check the label of any Doyle splint for its own dimensions.

Product Size or thickness listed Pack
Reuter splints Regular or large; 0.25 mm (thin) or 0.5 mm (thick) 5 pairs
Simple splint (1522000) 70 mm x 44 mm, 0.50 mm thick 10 pairs
Merocel silicone splint (400561) 1.0 mm thick 5 pairs
Thermasplints Small, medium, large 10 units

What to check on the label

The splint and size are chosen by the surgeon for the procedure. The Summit Medical IFU states that its internal splints are not intended for use except as indicated or prescribed by a physician. For buyers, the verifiable points are the ones on the label and in the IFU: whether the product is supplied sterile or non-sterile (when that distinction matters for purchasing) (the Summit product is non-sterile; the Doyle II airway set is supplied sterile), whether it is single use, and the dimensions in the manufacturer’s catalog.

Safe use and handling basics

  • The Summit IFU lists no known contraindications and names minor scar tissue and localized infection as possible adverse effects.
  • It states the product is not designed, sold or intended for use except as indicated or prescribed by a physician. Placement and removal are clinical tasks for the treating surgeon and are not described here.
  • Always follow the IFU supplied with the specific product (for dressings used alongside surgery, see What Is a Wound Dressing?), and a surgeon’s instructions for any patient.

Common mistakes

  • Treating external and internal splints as one product. They sit in different regulatory entries: 21 CFR 874.5800 covers the external splint, and internal septal splints appear under product code LYA.
  • Assuming one manufacturer’s IFU applies to every brand. Materials and sterility are product-specific.
  • Assuming a sterile and a non-sterile product are interchangeable. Check the packaging statement before stocking. For a related limb-support device, see Carpal Tunnel Splint.

Frequently asked questions

What is a Doyle nasal splint?

Doyle is a name used for a family of intranasal septal splints. Medtronic’s catalog lists a Doyle bi-valve septal splint and a Doyle II intranasal airway splint, and the GUDID record for the Doyle II airway set shows product code LYA (intranasal septal splint).

Are nasal splints used after septoplasty?

Internal splint instructions describe use for temporary, post-surgical splinting of the nasal septum, and Medtronic lists splints for support after septal and nasal surgery. Whether a splint is used in a given case is the surgeon’s decision.

Sources

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