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Coulmed TSK07-PR

by Coulmed Products Group LLC

Coulmed TSK07-PR is a Class I device made by Coulmed Products Group LLC, listed in FDA GUDID since 6 Jan 2023 (UDI-DI 10810087355392), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10810087355392 UDI-DI Date6 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Coulmed
Generic name
Operating table patient pressure distribution pad, reusable
Model / Ref / Catalog
TSK07-PR
Description
Replacement Pads for SKYTRON 3500 Surgical Table. 3 Piece Set; 2" thick. Tier II Pressure Relief Visco Foam with Black Skin-Soft Conductive Covering.
Primary DI / UDI-DI
10810087355392
FDA product code
LWG
GMDN term
Operating table patient pressure distribution pad, reusable
Device class
Class I
Regulation number
878.4950
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LWG (SURGICAL TABLE CUSHION).

Other devices from Coulmed Products Group LLC

See all devices from Coulmed Products Group LLC →

Properties

  • Convenience kit
  • Premarket exempt
Other properties (13, all answered No)