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Dornier Thulio Performance Fiber 270um Ball Tip Single Use

by Innovaquartz LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00816959021931 UDI-DI Date21 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Dornier Thulio Performance Fiber
Generic Name
General/multiple surgical laser system beam guide, reusable
Model / Ref / Catalog
270um Ball Tip Single Use, K2016368
Primary DI / UDI-DI
00816959021931
510(k) Number
FDA Product Code
GEX
GMDN Term
General/multiple surgical laser system beam guide, reusable
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K180140)

Show all (12)

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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