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PremierPro 3610

by Prestige Ameritech

PremierPro 3610 is a Class I device made by Prestige Ameritech, listed in FDA GUDID since 4 Aug 2020 (UDI-DI 00818566017710), 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 Number00818566017710 UDI-DI Date4 Aug 2020ListedStatusListed 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  • Withdrawn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
PremierPro
Generic name
Ear canal irrigation syringe
Model / Ref / Catalog
3610
Primary DI / UDI-DI
00818566017710
FDA product code
JYH
GMDN term
Ear canal irrigation syringe
Device class
Class I
Regulation number
874.4420
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ear canal irrigation syringe

Similar devices in this category

Other devices filed under Ear canal irrigation syringe.

Other devices from Prestige Ameritech

See all devices from Prestige Ameritech →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)