MICRON, droplet pen needle

FDA UDI

Class II (US FDA UDI)

by Htl Strefa S A

Identity

Trade Name: MICRON, droplet pen needle FDA UDI
Generic Name: Autoinjector needle FDA UDI
Device Name: Sterile, single use MICRON, droplet pen needles, intended to be used with a pen injector device for the subcutaneous injection of insulin. FDA UDI
Model / Reference: 34G x 3.5mm FDA UDI
Description: Sterile, single use MICRON, droplet pen needles, intended to be used with a pen injector device for the subcutaneous injection of insulin. FDA UDI

Identifiers

Catalog Number: 7914 FDA UDI
Primary DI / UDI-DI: 05907996096152 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

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

Category: Autoinjector needle

MICRON, droplet pen needle by Htl Strefa S A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Autoinjector needle.

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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
Sure Comfort — ALLISON MEDICAL, INC. · 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

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Manufacturer

Manufacturer: Htl Strefa S A

Sources (1)

FDA UDI 43a744f3-cbae-4b6b-8bd6-629739631832 37 fields · synced May 30, 2026