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Garyline Pztk

by Garyline LLC

Garyline Pztk is a Class I device made by Garyline LLC, listed in FDA GUDID since 28 Jun 2023 (UDI-DI 00661948005351), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00661948005351 UDI-DI Date28 Jun 2023ListedStatusListed 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  • Withdrawn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
Garyline
Generic name
Oral care kit, reusable
Model / Ref / Catalog
PZTK
Primary DI / UDI-DI
00661948005351
FDA product code
EFW, JES, EJR, NXZ
GMDN term
Oral care kit, reusable
Device class
Class I
Regulation number
872.6855, 872.6390, 872.6030
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EFW (Toothbrush, Manual).

Other devices from Garyline LLC

See all devices from Garyline LLC →

Properties

  • Convenience kit
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)