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, single-use FDA UDI
Device Name: Patient Safety Strapping, Double Sided Hook & Loop, Skin-Soft, Black Loop & White Hook, 6"W x 30' Long Roll, Cut to Size, Per Each FDA UDI
Model / Reference: PS-3006-716 FDA UDI
Description: Patient Safety Strapping, Double Sided Hook & Loop, Skin-Soft, Black Loop & White Hook, 6"W x 30' Long Roll, Cut to Size, Per Each FDA UDI

Identifiers

Catalog Number: PS-3006-716 FDA UDI
Primary DI / UDI-DI: 10810087353244 FDA UDI
FDA Product Code: FMQ FDA UDI
GMDN Term: Limb/torso/head restraint, single-use 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Limb/torso/head restraint, single-use

Coulmed by Coulmed Products Group Llc — 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: Coulmed Products Group Llc

Sources (1)

FDA UDI aeeb0e93-1028-4d5b-af4d-7d0908f710f4 34 fields · synced May 30, 2026