Identity
- Trade Name
- TriVerse X-Ray Digital Template, Tibial I-Beam FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Model / Reference
- 02-039-95-4159 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215114510 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical implant template, reusable
TriVerse X-Ray Digital Template, Tibial I-Beam by Signature Orthopaedics Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant template, reusable.
- Newclip Instruments — NEWCLIP TECHNICS · Class I
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
- Legion — Smith & Nephew, Inc. · Class II
- LIGAFIX® — S.B.M. SAS · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · 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
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI c154be2f-af87-400b-8973-84782401be18 32 fields · synced Jun 8, 2026