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NeuLight® WF IR600HCT 3/SM-F 2M20Z1C

by WEINERT Fiber Optics 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 Number00816901024034 UDI-DI Date12 Mar 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  • Withdrawn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
NeuLight®
Generic Name
Urogenital surgical laser system beam guide, single-use
Model / Ref / Catalog
WF IR600HCT 3/SM-F 2M20Z1C, 099471
Primary DI / UDI-DI
00816901024034
FDA Product Code
GEX
GMDN Term
Urogenital surgical laser system beam guide, single-use
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

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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