Identity
- Trade Name
- Coulmed FDA UDI
- Generic Name
- Limb/torso/head restraint, reusable FDA UDI
- Device Name
- Conductive Body & Leg Restraint Strap, Has 5'W part attached to a 2'W strap with 2 Airplane style Buckles, WITH Side Rail Hooks, Adjustable to 120" FDA UDI
- Model / Reference
- 153-1XL FDA UDI
- Description
- Conductive Body & Leg Restraint Strap, Has 5'W part attached to a 2'W strap with 2 Airplane style Buckles, WITH Side Rail Hooks, Adjustable to 120" FDA UDI
Identifiers
- Catalog Number
- 153-1XL FDA UDI
- Primary DI / UDI-DI
- 10810087353053 FDA UDI
- FDA Product Code
- FMQ FDA UDI
- GMDN Term
- Limb/torso/head restraint, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6760 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Limb/torso/head restraint, reusable
Coulmed by Coulmed Products Group Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
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
- Coulmed Products Group Llc
Sources (1)
- FDA UDI 32ce0bd9-e89b-45ba-bc89-1b12d21703e0 34 fields · synced May 30, 2026