← Back to catalogue

Coulmed

FDA UDI

Class I (US FDA UDI)

by Coulmed Products Group Llc

Identity

Trade Name
Coulmed FDA UDI
Generic Name
Operating table patient pressure distribution pad, reusable FDA UDI
Device Name
Custom Gel Pad 16"L x8.5" W x 2.63"H FDA UDI
Model / Reference
GP141 FDA UDI
Description
Custom Gel Pad 16"L x8.5" W x 2.63"H FDA UDI

Identifiers

Catalog Number
GP141 FDA UDI
Primary DI / UDI-DI
10810087351097 FDA UDI
FDA Product Code
LWG FDA UDI
GMDN Term
Operating table patient pressure distribution pad, 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: Operating table patient pressure distribution pad, reusable

Coulmed by Coulmed Products Group Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating table patient pressure distribution pad, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Coulmed Products Group Llc

Sources (1)

  • FDA UDI 29c80243-772a-4f6c-b41e-6163452be035 34 fields · synced May 30, 2026