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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
Arm procedure positioner, reusable FDA UDI
Device Name
Armboard Pad, Pressure Relief Memory Foam, 2"T x 6"W x 26"L FDA UDI
Model / Reference
AP226-PR FDA UDI
Description
Armboard Pad, Pressure Relief Memory Foam, 2"T x 6"W x 26"L FDA UDI

Identifiers

Catalog Number
AP226-PR FDA UDI
Primary DI / UDI-DI
10810087352889 FDA UDI
FDA Product Code
LWG FDA UDI
GMDN Term
Arm procedure positioner, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 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: Arm procedure positioner, reusable

Coulmed Arm Procedure Positioner is a preformed device designed to support and stabilize a patient's arm in a desired position during medical procedures, offering improved comfort and stability. This reusable device features adjustable height, tilt, rotation, and lock positioning capabilities, making it an essential tool for various medical specialties.

Similar devices

Also classified as Arm procedure positioner, reusable.

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 9cd90736-d903-4df3-bfc0-776d20129a34 34 fields · synced Jun 24, 2026