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Dornier MedTech 600 Micron Disposable

by Dornier MedTech GmbH 3 variants

Dornier MedTech 600 Micron Disposable (K2012146) is a general/multiple surgical laser system beam guide (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Dornier MedTech GmbH, listed in FDA GUDID since 11 Sep 2018 (UDI-DI 04049958001925), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04049958001925 UDI-DI Date11 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Dornier MedTech
Generic name
General/multiple surgical laser system beam guide, single-use
Model / Ref / Catalog
600 Micron Disposable, K2012146
Primary DI / UDI-DI
04049958001925
FDA product code
GEX
GMDN term
General/multiple surgical laser system beam guide, single-use
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)