Integra®

FDA UDI

Class I (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name: Integra® FDA UDI
Generic Name: Ear knife FDA UDI
Device Name: Integra® McCabe Culbertson Canal Knife, 6-1/2", 1.5mm Wide x 2mm Blade, Angled 45° FDA UDI
Model / Reference: 3722082 FDA UDI
Description: Integra® McCabe Culbertson Canal Knife, 6-1/2", 1.5mm Wide x 2mm Blade, Angled 45° FDA UDI

Identifiers

Catalog Number: 3722082 FDA UDI
Primary DI / UDI-DI: 10381780082019 FDA UDI
FDA Product Code: JYO FDA UDI
GMDN Term: Ear knife FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 2 Millimeter FDA UDI
Angle — 45 degree FDA UDI
Width — 1.5 Millimeter FDA UDI

Category: Ear knife

Integra® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ear knife.

V. Mueller — STERIS CORPORATION · Class I
JEDMED — JEDMED Instrument Company · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
BR Surgical, LLC — BR SURGICAL LLC · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
HNM MEDICAL — HNM STAINLESS, LLC. · Class I
Fisch sickle knife — Spiggle & Theis Medizintechnik GmbH · Class I
FENTEX — FENTEX medical GmbH · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Integra LifeSciences Production Corporation

Sources (1)

FDA UDI c57b29a2-bdd2-473c-a54f-a5b1f8619b88 36 fields · synced Jun 9, 2026