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Grafco 3918-1

by GF Health Products, Inc.

Grafco 3918-1 is a Class I device made by GF Health Products, Inc., listed in FDA GUDID since 12 Aug 2021 (UDI-DI M368391811), registry data as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM368391811 UDI-DI Date12 Aug 2021ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Grafco
Generic name
Ear canal irrigation syringe
Model / Ref / Catalog
3918-1
Primary DI / UDI-DI
M368391811
FDA product code
JZF
GMDN term
Ear canal irrigation syringe
Device class
Class I
Regulation number
874.4420
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket exempt
  • Lot / batch number
Other properties (13, all answered No)