Identity
- Trade Name
- Span-America FDA UDI
- Generic Name
- Operating table patient pressure distribution pad, single-use FDA UDI
- Device Name
- ESSENTIAL MED 4"P .5"B T FDA UDI
- Model / Reference
- Convoluted Rollpack FDA UDI
- Description
- ESSENTIAL MED 4"P .5"B T FDA UDI
Identifiers
- Catalog Number
- F9012E FDA UDI
- Primary DI / UDI-DI
- H933F9012E0 FDA UDI
- FDA Product Code
- IKY FDA UDI
- GMDN Term
- Operating table patient pressure distribution pad, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5150 FDA UDI
- Commercial Distribution
- Not 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
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
Span-America by Span-America Medical Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Span-America Medical Systems, Inc.
Sources (1)
- FDA UDI 5394541f-ccb1-472d-88bf-00908b177e55 35 fields · synced Jun 12, 2026