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Expd 4343D

by Drtech Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800018408308 UDI-DI Date17 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Indirect flat panel x-ray detector
Model / Reference
EXPD 4343D
Primary DI / UDI-DI
08800018408308
510(k) Number
FDA Product Code
MQB
GMDN Term
Indirect flat panel x-ray detector
Device Class
Class II
Regulation Number
892.1680
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K232753)

Other devices from Drtech Corp.

See all devices from Drtech Corp. →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No