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iXRS AirDR G3+

by Icrco, Inc.

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

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 Number00854810007199 UDI-DI Date22 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
iXRS
Generic Name
Stationary basic diagnostic x-ray system, digital
Model / Ref / Catalog
AirDR G3+, INT-XRS-UNI-KIT
Primary DI / UDI-DI
00854810007199
FDA Product Code
JAA
GMDN Term
Stationary basic diagnostic x-ray system, digital
Device Class
Class II
Regulation Number
892.1650
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Icrco, Inc.

See all devices from Icrco, Inc. →

Properties

  • Prescription Use
  • Convenience Kit

Other properties (12)

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