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Ultra-Fine 328440

by embecta Medical II LLC

Ultra-Fine 328440 is a Class II device made by embecta Medical II LLC, listed in FDA GUDID since 22 Nov 2024 (UDI-DI 00383017844011), 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 Number00383017844011 UDI-DI Date22 Nov 2024ListedStatusListed 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  • Withdrawn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
Ultra-Fine
Generic name
Insulin syringe/needle, basic
Model / Ref / Catalog
328440
Primary DI / UDI-DI
00383017844011
FDA product code
FMF
GMDN term
Insulin syringe/needle, basic
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 31 Gauge
Length — 8 Millimeter

Related devices

Category: Insulin syringe/needle, basic

Similar devices

Other devices filed under FDA product code FMF (Syringe, piston).

Other devices from embecta Medical II LLC

See all devices from embecta Medical II LLC →

Properties

  • Supplied sterile
  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)