Identity
- Trade Name
- T-FIX FDA UDI
- Generic Name
- Suture cutter, reusable FDA UDI
- Device Name
- CUTTER SUTURE T-FIX FDA UDI
- Model / Reference
- 014527 FDA UDI
- Description
- CUTTER SUTURE T-FIX FDA UDI
Identifiers
- Catalog Number
- 014527 FDA UDI
- Primary DI / UDI-DI
- 03596010402295 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Suture cutter, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
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: Suture cutter, reusable
T-Fix by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suture cutter, reusable.
- SUPER MAXCUTTER — Biomet Orthopedics, Inc. · Class I
- Suture Cutter — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Tigon Medical — TIGON MEDICAL LLC · Class I
- Hip Flush Cutter — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Rotary Hook Scissors Straight shaft, jaw 20° angled right — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- 2.3MM DISPOSABLE MAXCUTTER — Biomet Orthopedics, Inc. · Class I
- Trim Cord — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- MAXCUTTER SIDE LOAD DISPOSABLE — Biomet Orthopedics, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI c0a4445f-55fd-4ec2-b1d9-d7c624f1aa46 35 fields · synced Jun 8, 2026