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Coulmed GP616

by Coulmed Products Group LLC

Coulmed GP616 is a Class I device made by Coulmed Products Group LLC, listed in FDA GUDID since 6 Jan 2023 (UDI-DI 10810087351776), 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 Number10810087351776 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  • Withdrawn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
Freestanding patient positioner, reusable
Model / Ref / Catalog
GP616
Primary DI / UDI-DI
10810087351776
FDA product code
CCX
GMDN term
Freestanding patient positioner, reusable
Device class
Class I
Regulation number
868.6820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Freestanding patient positioner, reusable

Similar devices

Other devices filed under FDA product code CCX (SUPPORT, PATIENT POSITION).

Other devices from Coulmed Products Group LLC

See all devices from Coulmed Products Group LLC →

Properties

  • Premarket exempt
Other properties (14, all answered No)