Identity
- Trade Name
- TrenGuard™ FDA UDI
- Generic Name
- Operating table patient positioning set, single-use FDA UDI
- Device Name
- TrenGuard Patient Positioning Kit Hillrom US - Includes TrenGuard Patient Support Frame (00811836030006) and one TrenGuard 600 CLASSIC Pack (00811836030174) in a TrenGuard CarryCase with a case of TrenGuard 450 CLASSIC Packs (20811836030086 12 each 00811836030082) FDA UDI
- Model / Reference
- 81012 FDA UDI
- Description
- TrenGuard Patient Positioning Kit Hillrom US - Includes TrenGuard Patient Support Frame (00811836030006) and one TrenGuard 600 CLASSIC Pack (00811836030174) in a TrenGuard CarryCase with a case of TrenGuard 450 CLASSIC Packs (20811836030086 12 each 00811836030082) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811836030785 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Operating table patient positioning set, 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Operating table patient positioning set, single-use
TrenGuard™ by Dan Allen Surgical — 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
- Dan Allen Surgical
Sources (1)
- FDA UDI a8f121c5-8990-40de-95be-7f356f948c64 33 fields · synced Jun 6, 2026