Hsw Soft-Ject®

FDA UDI

Class II (US FDA UDI)

by Henke-Sass, Wolf GmbH

Identity

Trade Name: HSW SOFT-JECT® FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Device Name: 2 ML (2,5 ML) HSW SOFT-JECT® BK 0,80X40/21GX11/2 FDA UDI
Model / Reference: 5022D000V0 FDA UDI
Description: 2 ML (2,5 ML) HSW SOFT-JECT® BK 0,80X40/21GX11/2 FDA UDI

Identifiers

Catalog Number: 5022D000V0 FDA UDI
Primary DI / UDI-DI: 04035873017042 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: General-purpose syringe, single-use 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

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: Total Volume — 2 Milliliter FDA UDI

Category: General-purpose syringe, single-use

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

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Merit Medical® — Merit Medical Systems, 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 a85652ed-c5d6-4721-8e48-d82463de5940 36 fields · synced Jun 1, 2026