Identity
- Trade Name
- UNIUM FDA UDI
- Generic Name
- Bone/joint surgical power tool motor, electric FDA UDI
- Device Name
- UNIUM(TM) MODULAR HANDPIECE FDA UDI
- Model / Reference
- 05.001.601 FDA UDI
- Description
- UNIUM(TM) MODULAR HANDPIECE FDA UDI
Identifiers
- Catalog Number
- 05001601 FDA UDI
- Primary DI / UDI-DI
- 10886982309549 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Bone/joint surgical power tool motor, electric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone/joint surgical power tool motor, electric
Unium by Synthes — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone/joint surgical power tool motor, electric.
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions · Class II
- Brasseler EZX — IMEDICOM CO., LTD. · Class I
- Adler Instrument Company — Adler, Inc. · Class II
- Midas Rex® — Medtronic Powered Surgical Solutions · Class II
- Midas Rex® — Medtronic Powered Surgical Solutions · Class II
- Brasseler EZX — IMEDICOM CO., LTD. · Class I
- Brasseler EZX — IMEDICOM CO., LTD. · Class I
- EZX — IMEDICOM CO., LTD. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Synthes
Sources (1)
- FDA UDI e0216d03-8496-4945-8e42-02647ac961b2 35 fields · synced Jun 8, 2026