Identity
- Trade Name
- TenZor FDA UDI
- Generic Name
- Traction boot FDA UDI
- Device Name
- The TenZor Carbon Fiber Traction Unit Assembly is lightweight and tension adjustable. The unit attaches to the Abductor Bars of Orthopedic Tables by means of a Traction Accessory clamp to hold Foot Traction boot and Pad (included) in place to pull Traction. FDA UDI
- Model / Reference
- BF72 FDA UDI
- Description
- The TenZor Carbon Fiber Traction Unit Assembly is lightweight and tension adjustable. The unit attaches to the Abductor Bars of Orthopedic Tables by means of a Traction Accessory clamp to hold Foot Traction boot and Pad (included) in place to pull Traction. FDA UDI
Identifiers
- Catalog Number
- BF72 FDA UDI
- Primary DI / UDI-DI
- 00724995165345 FDA UDI
- FDA Product Code
- HST FDA UDI
- GMDN Term
- Traction boot FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.5850 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Category: Traction boot
TenZor by Steris Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Traction boot.
- Active Heel Traction Boot — Smith & Nephew, Inc. · Class I
- Paradigm Revolution — Conmed Corporation · Class I
- ADANTE TRACTION BOOT, EX LARGE, PAIR — Mizuho Orthopedic Systems, Inc. · Class I
- SPLINT, UNIVERSAL BUCK'S TRACTION — Mizuho Orthopedic Systems, Inc. · Class I
- Active Heel Traction Boot — Smith & Nephew, Inc. · Class I
- Active Heel Traction Boot — Smith & Nephew, Inc. · Class I
- Active Heel Traction Boot — Smith & Nephew, Inc. · Class I
- Arthrex® — Arthrex, 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
- Steris Corporation
Sources (1)
- FDA UDI f04a943b-7b4e-4633-a5c9-cb016e4453e0 35 fields · synced Jun 8, 2026