Identity
- Trade Name
- ALLEN FDA UDI
- Generic Name
- Traction boot FDA UDI
- Device Name
- ATB- Modular Attach for Mizuho OSI Syss FDA UDI
- Model / Reference
- 108001 FDA UDI
- Description
- ATB- Modular Attach for Mizuho OSI Syss FDA UDI
Identifiers
- Catalog Number
- A-93007 FDA UDI
- Primary DI / UDI-DI
- 00615521004286 FDA UDI
- FDA Product Code
- FWZ FDA UDI
- GMDN Term
- Traction boot FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Traction boot
Allen by Hill-Rom, Inc. — 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
- Hill-Rom, Inc.
Sources (1)
- FDA UDI d9afc54e-12d7-4010-99ac-51d6234a75c3 35 fields · synced May 31, 2026