Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Metal/carbide ENT bur, reusable FDA UDI
- Device Name
- BUR,CUTTING 70MM X 0.5MM DIA FDA UDI
- Model / Reference
- 70327032 FDA UDI
- Description
- BUR,CUTTING 70MM X 0.5MM DIA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925029941 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Metal/carbide ENT bur, reusable
Gyrus ACMI by Gyrus Acmi, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal/carbide ENT bur, reusable.
- Tungst.Carb.Burr, Ø1.4x70mm, 50k — Bien-Air Surgery SA · Class I
- Bur PM2-70 50K Steel Ø4.0 — Bien-Air Surgery SA · Class I
- Bur PM2-70 50K Carb Ø0.5 — Bien-Air Surgery SA · Class I
- Oto-Flex — MEDTRONIC XOMED, INC. · Class II
- Bur PM2-70 50K Carb Ø6.0 — Bien-Air Surgery SA · Class I
- Tungst.Carb.Burr, Ø0.5x70mm, 50k — Bien-Air Surgery SA · Class I
- FENTEX — FENTEX medical GmbH · Class I
- Bur PM2-70 50K Carb Xcut 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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 43f6b91a-5443-43e8-b97a-637cad141d2b 33 fields · synced Jun 8, 2026