Identity
- Trade Name
- BIOSURE FDA UDI
- Generic Name
- Orthopaedic graft tensioner, reusable FDA UDI
- Device Name
- BIOSURE SYNC TENSIONER FDA UDI
- Model / Reference
- 72202754 FDA UDI
- Description
- BIOSURE SYNC TENSIONER FDA UDI
Identifiers
- Catalog Number
- 72202754 FDA UDI
- Primary DI / UDI-DI
- 03596010649027 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Orthopaedic graft tensioner, reusable FDA UDI
Classification
- Device Class
- Class I 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
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: Orthopaedic graft tensioner, reusable
Biosure by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic graft tensioner, reusable.
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- X-Wing Sliding Base — ENZTEC LIMITED · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- ACL GRAFT TENSIONER — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 47853efe-4a67-4f2c-b672-7ad5a7b0ad2e 35 fields · synced Jun 8, 2026