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iQ®200 iQ® Lamina™ Case of 4 x 7 L

by Iris International, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10837461002116 UDI-DIDate7 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
iQ®200
Generic Name
Wash/cleaning solution IVD, automated/semi-automated system
Model / Ref / Catalog
iQ® Lamina™ Case of 4 x 7 L, 800-3102
Primary DI / UDI-DI
10837461002116
FDA Product Code
PPM
GMDN Term
Wash/cleaning solution IVD, automated/semi-automated system
Device Class
Class I
Regulation Number
864.4010
GUDID distribution status
Not in Commercial Distribution

Other devices from Iris International, Inc.

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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