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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, single-use FDA UDI
Device Name
Cotton Leg Holder Straps for Candy Cane Stirrups (Item #AC20): 1"W Strap with O-Rings, makes two loops. _x000D_ _x000D_ Old item # 159-4 FDA UDI
Model / Reference
AC20-SP FDA UDI
Description
Cotton Leg Holder Straps for Candy Cane Stirrups (Item #AC20): 1"W Strap with O-Rings, makes two loops. _x000D_ _x000D_ Old item # 159-4 FDA UDI

Identifiers

Catalog Number
AC20-SP FDA UDI
Primary DI / UDI-DI
10810087353220 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

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, single-use

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, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coulmed Products Group Llc

Sources (1)

  • FDA UDI 02fe7fa0-fc87-403f-b286-ee63b34e6694 34 fields · synced May 30, 2026