Identity
- Trade Name
- SYNFIX Evolution FDA UDI
- Generic Name
- Surgical instrument guard, single-use FDA UDI
- Device Name
- SYNFIX® EVO PROTECTION SLEEVE 3-PACK F/SCREWDRIVER/AWL-STER FDA UDI
- Model / Reference
- 03.835.012S FDA UDI
- Description
- SYNFIX® EVO PROTECTION SLEEVE 3-PACK F/SCREWDRIVER/AWL-STER FDA UDI
Identifiers
- Catalog Number
- 03835012S FDA UDI
- Primary DI / UDI-DI
- 10705034814216 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical instrument guard, single-use 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
No
FDA UDI
Category: Surgical instrument guard, single-use
SYNFIX Evolution by Synthes — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument guard, single-use.
- Oxboro ™ DuoGuard™ Instrument Tip Protectors — Aspen Surgical Products, Inc. · Class I
- ARROW — TELEFLEX INCORPORATED · Class II
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Oxboro ™ Osteotome Tip Protectors — Aspen Surgical Products, Inc. · Class I
- Simpulse — Davol Inc. · Class II
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Steri-Pocket — Hanes Companies, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · 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 5374d643-1b0f-425d-9901-f4e322b18bda 35 fields · synced May 30, 2026