Identity
- Trade Name
- BoneFoam FDA UDI
- Generic Name
- Freestanding patient positioner, reusable FDA UDI
- Device Name
- Pediatric Leg Tunnel with Straps FDA UDI
- Model / Reference
- 925.PULT2-WS FDA UDI
- Description
- Pediatric Leg Tunnel with Straps FDA UDI
Identifiers
- Catalog Number
- 925.PULT2-WS FDA UDI
- Primary DI / UDI-DI
- 00810075280265 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Freestanding patient positioner, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 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
No
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Length — 24.5 Inch FDA UDI
Category: Freestanding patient positioner, reusable
BoneFoam by Bone Foam, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Freestanding patient positioner, reusable.
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- Rayshield — AADCO MEDICAL, INC. · Class I
- Coulmed — COULMED PRODUCTS GROUP LLC · 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
- Bone Foam, Inc.
Sources (1)
- FDA UDI 06798709-07eb-4c56-bb93-b721166b32b7 35 fields · synced Jun 8, 2026