Identity
- Trade Name
- SynFix FDA UDI
- Generic Name
- Orthopaedic implant aiming/guiding block attachment tool FDA UDI
- Device Name
- 15MM SYNFIX MINI-OPEN FIXED HANDLE AIMING DEVICE FDA UDI
- Model / Reference
- 03.802.205 FDA UDI
- Description
- 15MM SYNFIX MINI-OPEN FIXED HANDLE AIMING DEVICE FDA UDI
Identifiers
- Catalog Number
- 03802205 FDA UDI
- Primary DI / UDI-DI
- 10705034722337 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Orthopaedic implant aiming/guiding block attachment tool FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
SynFix by Synthes (u.s.a.) Lp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Synthes (u.s.a.) Lp
Sources (1)
- FDA UDI fd3a05d8-8c7c-41f0-9034-89335a754757 36 fields · synced Jun 1, 2026