Identity
- Trade Name
- Zimmer FDA UDI
- Generic Name
- Burring power tool attachment FDA UDI
- Model / Reference
- 5979-95-38 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B504OM597995380 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Burring power tool attachment FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Burring power tool attachment
Zimmer by Provision — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Burring power tool attachment.
- Midas Rex MR8 — Medtronic Powered Surgical Solutions · Class II
- Midas Rex® — Medtronic Powered Surgical Solutions · Class II
- Midas Rex — Medtronic Powered Surgical Solutions · Class II
- Midas Rex MR8 — Medtronic Powered Surgical Solutions · Class II
- MR8 Attachments — Medtronic Powered Surgical Solutions · Class II
- ELAN 4 — AESCULAP, INC. · Class I
- ELAN 4 — AESCULAP, INC. · Class I
- MIDAS REX™ — Medtronic Powered Surgical Solutions · Class II
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
- Provision
Sources (1)
- FDA UDI 8d426199-2c7d-4428-a325-91d8532c00e4 33 fields · synced Jun 1, 2026