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Coulmed

FDA UDI

Class I (US FDA UDI)

by Coulmed Products Group Llc

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, without Side Rail Hooks, Adjustable to 96" FDA UDI
Model / Reference
153-1WOH FDA UDI
Description
Conductive Body & Leg Restraint Strap, Has 5"W part attached to a 2"W strap with 2 Airplane style Buckles, without Side Rail Hooks, Adjustable to 96" FDA UDI

Identifiers

Catalog Number
153-1WOH FDA UDI
Primary DI / UDI-DI
10810087353039 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

Similar devices

Also classified as Limb/torso/head restraint, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI ea575ed5-bed9-488d-9fe5-2de253773336 34 fields · synced Jun 1, 2026