Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Freestanding patient positioner, single-use FDA UDI
- Device Name
- FOAM POSITIONER OR TABLE POSITIONING KITS TRENDELENBURG PAD POLYURETHANE FOAM BLUE INCLUDES EXTRA LARGE TRENDELENBURG PAD X1 CHEST PAD X1 BODY STRAP X1 HEAD POSITIONER X1 PAIR OF TRENDELENBURG ARM PROTECTORS X1 DISPOSABLE NOT MADE WITH NATURAL RUBBER LATEX HALYARD FDA UDI
- Model / Reference
- 48743 FDA UDI
- Description
- FOAM POSITIONER OR TABLE POSITIONING KITS TRENDELENBURG PAD POLYURETHANE FOAM BLUE INCLUDES EXTRA LARGE TRENDELENBURG PAD X1 CHEST PAD X1 BODY STRAP X1 HEAD POSITIONER X1 PAIR OF TRENDELENBURG ARM PROTECTORS X1 DISPOSABLE NOT MADE WITH NATURAL RUBBER LATEX HALYARD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632373336 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Freestanding patient positioner, single-use 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Freestanding patient positioner, single-use
Halyard by Owens & Minor Distribution, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI 91a6be4d-b482-4e5b-8200-80b9a9977c2b 33 fields · synced Jun 8, 2026