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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
1ml, 31G 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
6004 FDA UDI
Primary DI / UDI-DI
05907996095612 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

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

Similar devices

Also classified as Insulin syringe/needle, basic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Htl Strefa S A

Sources (1)

  • FDA UDI 5145c9d2-3c9b-489c-aac4-2f679851e767 35 fields · synced May 29, 2026