FDA UDI
In Commercial Distribution
🇺🇸 United States
HSW HENKE-JECT®
DI: 04035873027195
·
Model: 2118000077
·
Henke-Sass, Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HSW HENKE-JECT®
- Primary DI
- 04035873027195
- Version / Model
- 2118000077
- Catalog Number
- 2118000077
- Company Name
- Henke-Sass, Wolf GmbH
- Labeler DUNS
- 317326411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 18e444ce-e1a2-449b-9814-44d40a02a7ae
Device Description
HSW HENKE-JECT® 1,8 ML US
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJI | Syringe, Cartridge | Dental | 872.6770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35869 | Dental anaesthesia syringe, intraligamentary | A hand-held manual dental device designed for injecting an anaesthetic agent under pressure via the periodontal ligament or into bone through an attached sterile needle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04035873027195 | GS1 |