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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
Operating table patient pressure distribution pad, reusable FDA UDI
Device Name
Replacement Pad for Skytron #1700 O.R. Table, 2" Standard Foam, 3 Piece Set, Deluxe Covering FDA UDI
Model / Reference
TSK13 FDA UDI
Description
Replacement Pad for Skytron #1700 O.R. Table, 2" Standard Foam, 3 Piece Set, Deluxe Covering FDA UDI

Identifiers

Catalog Number
TSK13 FDA UDI
Primary DI / UDI-DI
10810087355842 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

Yes

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

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Manufacturer

Manufacturer
Coulmed Products Group Llc

Sources (1)

  • FDA UDI 3b97dc92-00d2-4d6d-9be9-b18d6e2319ef 34 fields · synced May 30, 2026