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Integra®

FDA UDI

Class I (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name
Integra® FDA UDI
Generic Name
Middle ear file/rasp FDA UDI
Device Name
McCabe Perforation Rasp FDA UDI
Model / Reference
3722086 FDA UDI
Description
McCabe Perforation Rasp FDA UDI

Identifiers

Catalog Number
3722086 FDA UDI
Primary DI / UDI-DI
10381780082057 FDA UDI
FDA Product Code
JYY FDA UDI
GMDN Term
Middle ear file/rasp 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Middle ear file/rasp

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

Similar devices

Also classified as Middle ear file/rasp.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra LifeSciences Production Corporation

Sources (1)

  • FDA UDI 2526b001-584d-4ac1-869e-c9977a53b809 36 fields · synced Jun 9, 2026