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Na B50B603

by Ophthalmed LLC

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 NumberM735B50B6031 UDI-DI Date22 Sep 2022ListedStatusListed 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  • Withdrawn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
Ophthalmic laser system beam guide
Model / Reference
B50B603
Primary DI / UDI-DI
M735B50B6031
510(k) Number
FDA Product Code
HQB
GMDN Term
Ophthalmic laser system beam guide
Device Class
Class II
Regulation Number
886.4690
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 23 Gauge

Related devices

Category: Ophthalmic laser system beam guide

Cleared under the same submission (K142830)

Other devices from Ophthalmed LLC

See all devices from Ophthalmed LLC →

Properties

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

Other properties (9)

  • 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