Identity
- Trade Name
- UNIUM FDA UDI
- Generic Name
- Sternum saw blade guide FDA UDI
- Device Name
- UNIUM(TM) TOP FOR STERNUM FOR RECIP SAW HANDPIECE FDA UDI
- Model / Reference
- 05.001.612 FDA UDI
- Description
- UNIUM(TM) TOP FOR STERNUM FOR RECIP SAW HANDPIECE FDA UDI
Identifiers
- Catalog Number
- 05001612 FDA UDI
- Primary DI / UDI-DI
- 10886982309594 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Sternum saw blade guide 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: Sternum saw blade guide
Unium by Synthes — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sternum saw blade guide.
- Zimmer Biomet™ X Series Power System — Zimmer Surgical SA · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- Zimmer Biomet™ X Series Power System — Zimmer Surgical SA · Class I
- De Soutter Medical — De Soutter Medical, 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 520ee85e-6b8f-4505-8213-0582a9a8a01a 35 fields · synced May 30, 2026