Unifine Safe Control

FDA UDI

Class II (US FDA UDI)

by Owen Mumford Usa Incorporated

Identity

Trade Name: Unifine Safe Control FDA UDI
Generic Name: Autoinjector needle FDA UDI
Device Name: Unifine Safe Control Pen Needles 8mm x 30G Sample Bags FDA UDI
Model / Reference: AN 0935SB2 FDA UDI
Description: Unifine Safe Control Pen Needles 8mm x 30G Sample Bags FDA UDI

Identifiers

Primary DI / UDI-DI: 00384700935214 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Autoinjector needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 8 Millimeter FDA UDI
Needle Gauge — 30 Gauge FDA UDI

Category: Autoinjector needle

Unifine Safe Control by Owen Mumford Usa Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Autoinjector needle.

MICRON, droplet pen needle — HTL STREFA S A · Class II
SureFine Pen Needle 31Gx8mm — SHINA MED CORPORATION · Class II
EasyDrip Pen Needles 30G 8mm — Sandstone Medical (Suzhou) Inc. · Class II
droplet®, pen needles — HTL STREFA S A · Class II
Nano 2nd Gen — embecta Medical II LLC · Class II
BD Ultra-Fine — BECTON DICKINSON PEN LIMITED · Class II
Insulin Pen Needle — Berpu Medical Technology Co., Ltd · Class II
ONE-CARE Pen Needles — MediVena, LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Owen Mumford Usa Incorporated

Sources (1)

FDA UDI e36de00a-f6f3-4c6a-bbfd-8f63c3845c3d 36 fields · synced Jun 1, 2026