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iChopper IC-27G

by Medimax Tech Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817325025010 UDI-DIDate30 Apr 2026ListedStatusListed GUDID: 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  • Withdrawn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 22 Oct 2026.

Specification

GUDID

Trade Name
iChopper
Generic Name
Ophthalmic fibreoptic light instrument, single-use
Model / Reference
IC-27G
Primary DI / UDI-DI
00817325025010
510(k) Number
FDA Product Code
MPA
GMDN Term
Ophthalmic fibreoptic light instrument, single-use
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution

Other devices from Medimax Tech Inc.

See all devices from Medimax Tech Inc. →

Properties

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

Other properties (8)

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