droplet insulin syringes

FDA UDI

Class II (US FDA UDI)

by Htl Strefa S A

Identity

Trade Name: droplet insulin syringes FDA UDI
Generic Name: Insulin syringe/needle, basic FDA UDI
Device Name: droplet insulin syringes with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. FDA UDI
Model / Reference: 0.5ml, 30G x 8 mm FDA UDI
Description: droplet insulin syringes with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. FDA UDI

Identifiers

Catalog Number: 6013 FDA UDI
Primary DI / UDI-DI: 05907996095698 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Insulin syringe/needle, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 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

Category: Insulin syringe/needle, basic

droplet insulin syringes by Htl Strefa S A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 6dafe88d-d326-468a-8717-bd62a1714ddc 35 fields · synced Jun 8, 2026