Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- Metal/carbide ENT bur, reusable FDA UDI
- Device Name
- Integra® Hough Stapedial Foot Plate Auger, 5-3/4", 0.8mm Drill Size Flat End, Drill 15mm Long FDA UDI
- Model / Reference
- 3722033 FDA UDI
- Description
- Integra® Hough Stapedial Foot Plate Auger, 5-3/4", 0.8mm Drill Size Flat End, Drill 15mm Long FDA UDI
Identifiers
- Catalog Number
- 3722033 FDA UDI
- Primary DI / UDI-DI
- 10381780081562 FDA UDI
- FDA Product Code
- EQJ FDA UDI
- GMDN Term
- Metal/carbide ENT bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4140 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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.8 Millimeter FDA UDILength — 15 Millimeter FDA UDI
Category: Metal/carbide ENT bur, reusable
Integra® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- GYRUS ACMI — Gyrus Acmi, Inc. · 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 |
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Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI d179f5f0-3e1d-4c05-9abe-b4d0a243978e 36 fields · synced Jun 9, 2026