Skip to content

Luxator L3A TiN

by Directa AB

Luxator L3A TiN (506436U) is a Class I device made by Directa AB, listed in FDA GUDID since 7 Dec 2022 (UDI-DI 17310231050324), 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 Number17310231050324 UDI-DI Date7 Dec 2022ListedStatusListed 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  • Withdrawn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
Luxator
Generic name
Periotome, reusable
Model / Ref / Catalog
L3A TiN, 506436U
Primary DI / UDI-DI
17310231050324
FDA product code
EMJ
GMDN term
Periotome, reusable
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Directa AB

See all devices from Directa AB →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)