Hsw Fine-Ject®

FDA UDI

Class II (US FDA UDI)

by Henke-Sass, Wolf GmbH

Identity

Trade Name: HSW FINE-JECT® FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: HSW FINE-JECT® 0,50X16MM / 25GX5/8" STERILE SHORT BEVEL FDA UDI
Model / Reference: 8300015021 FDA UDI
Description: HSW FINE-JECT® 0,50X16MM / 25GX5/8" STERILE SHORT BEVEL FDA UDI

Identifiers

Catalog Number: 8300015021 FDA UDI
Primary DI / UDI-DI: 04035873037149 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Hypodermic needle, single-use 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

Dimensions & Sizes

Size: Length — 16 Millimeter FDA UDI
Outer Diameter — 0.50 Millimeter FDA UDI

Category: Hypodermic needle, single-use

Hsw Fine-Ject® by Henke-Sass, Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hypodermic needle, single-use.

Monoject — Cardinalhealth · Class II
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Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
EasyTouch — MHC Medical Products · Class II
STERiJECT TM — TSK LABORATORY, JAPAN · Class II
Comfort EZ Pro — S.D.I. USA, 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: Henke-Sass, Wolf GmbH

Sources (1)

FDA UDI c48078d2-f82c-474b-843d-02dfccada60e 36 fields · synced Jun 1, 2026