Identity
- Trade Name
- ArmGuard™ FDA UDI
- Generic Name
- Medical table restraint anchor FDA UDI
- Device Name
- ArmGuard Classic Sled Kit - Includes 2 Standard Sleds (00811836030372) and 2 Bariatric Sleds (00811836030389), for use with ArmGuard Packs and accessories FDA UDI
- Model / Reference
- 40004 FDA UDI
- Description
- ArmGuard Classic Sled Kit - Includes 2 Standard Sleds (00811836030372) and 2 Bariatric Sleds (00811836030389), for use with ArmGuard Packs and accessories FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811836030365 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Medical table restraint anchor 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: Medical table restraint anchor
ArmGuard™ 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 42a666a0-b5cc-45ba-9763-74ebe202ef8a 33 fields · synced May 31, 2026