Identity
- Trade Name
- HSW HENKE-JECT® FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- HSW HENKE-JECT® 22G X 2 3/4 - 0,70 X 70 MM - RW /LB FDA UDI
- Model / Reference
- 22Gx2 3/4-0,70x70 FDA UDI
- Description
- HSW HENKE-JECT® 22G X 2 3/4 - 0,70 X 70 MM - RW /LB FDA UDI
Identifiers
- Catalog Number
- 8300059225 FDA UDI
- Primary DI / UDI-DI
- 04035873071105 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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: Hypodermic needle, single-use
Hsw Henke-Ject® by Henke-Sass, Wolf GmbH — 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
- Henke-Sass, Wolf GmbH
Sources (1)
- FDA UDI 36a98d8a-8f41-47f3-a888-c9218eba6035 35 fields · synced Jun 8, 2026