Identity
- Trade Name
- TOMOFIX FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- TOMOFIX(TM) OSTEOTOMY GAP MEASURING DEVICE FDA UDI
- Model / Reference
- 395.001 FDA UDI
- Description
- TOMOFIX(TM) OSTEOTOMY GAP MEASURING DEVICE FDA UDI
Identifiers
- Catalog Number
- 395001 FDA UDI
- Primary DI / UDI-DI
- 10886982200112 FDA UDI
- FDA Product Code
- HTJ FDA UDI
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4300 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: Surgical depth gauge, reusable
Tomofix by Synthes — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical depth gauge, reusable.
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- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · 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 |
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Manufacturer
- Manufacturer
- Synthes
Sources (1)
- FDA UDI 471f6bc5-e0c0-48ed-ae22-9963d34ec387 35 fields · synced May 31, 2026