Identity
- Trade Name
- Oto-Flex FDA UDI
- Generic Name
- Metal/carbide ENT bur, reusable FDA UDI
- Device Name
- TREPHINE 3155628 OTO-FLEX 0.8MM BLACK FDA UDI
- Model / Reference
- 3155628 FDA UDI
- Description
- TREPHINE 3155628 OTO-FLEX 0.8MM BLACK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00681490070430 FDA UDI
- FDA Product Code
- EQJ FDA UDIERL FDA UDI
- GMDN Term
- Metal/carbide ENT bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4140 FDA UDI874.4250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.8 Millimeter FDA UDI
Category: Metal/carbide ENT bur, reusable
Oto-Flex by Medtronic Xomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metal/carbide ENT bur, reusable.
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- GYRUS ACMI — Gyrus Acmi, Inc. · Class I
- GYRUS ACMI — Gyrus Acmi, Inc. · Class I
- Bur PM2-70 50K Carb Ø6.0 — Bien-Air Surgery SA · 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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 9c9afdd2-9a1a-4bf4-aef3-f3f203e0da96 35 fields · synced May 30, 2026