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iDR 34

by Icrco, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00854810007120 UDI-DI Date22 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
iDR
Generic Name
Indirect flat panel x-ray detector
Model / Ref / Catalog
34, 500-0177-124
Primary DI / UDI-DI
00854810007120
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
MRI Safety
MR Unsafe

Other devices from Icrco, Inc.

See all devices from Icrco, Inc. →

Properties

  • Prescription Use

Other properties (13)

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