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Drgem Pbt-6

by DRGEM Corporation 2 variants

Drgem Pbt-6 is a Class II device made by DRGEM Corporation, listed in FDA GUDID since 29 May 2017 (UDI-DI 08800011101022), 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 Number08800011101022 UDI-DI Date29 May 2017ListedStatusListed 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  • Withdrawn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
Drgem
Generic name
Basic diagnostic x-ray system table, powered
Model / reference
PBT-6
Primary DI / UDI-DI
08800011101022
FDA product code
IZZ
GMDN term
Basic diagnostic x-ray system table, powered
Device class
Class II
Regulation number
892.1980
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic diagnostic x-ray system table, powered

Other devices from DRGEM Corporation

See all devices from DRGEM Corporation →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)