Identity
- Trade Name
- Skytron FDA UDI
- Generic Name
- Operating table patient pressure distribution pad, reusable FDA UDI
- Device Name
- Pediatric Extension Pad 3 Inch FDA UDI
- Model / Reference
- 4-031-03-3WS FDA UDI
- Description
- Pediatric Extension Pad 3 Inch FDA UDI
Identifiers
- Catalog Number
- 4-031-03-3WS FDA UDI
- Primary DI / UDI-DI
- 10841736121495 FDA UDI
- FDA Product Code
- LWG FDA UDI
- GMDN Term
- Operating table patient pressure distribution pad, reusable 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Operating table patient pressure distribution pad, reusable
A comprehensive medical device directory for the Pediatric Extension Pad 3 Inch. This product is a reusable Operating Table Patient Pressure Distribution Pad, designed to prevent pressure sores and tissue necrosis on prominent parts of the body when immobilized for extended periods during surgery.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Skytron, LLC
Sources (1)
- FDA UDI 93d2d517-19a5-4ba4-92df-a48cee7a57e9 36 fields · synced Jul 22, 2026