FDA UDI
In Commercial Distribution
🇺🇸 United States
HSW FINE-JECT®
DI: 04035873035794
·
Model: 8300014301
·
Henke-Sass, Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- HSW FINE-JECT®
- Primary DI
- 04035873035794
- Version / Model
- 8300014301
- Catalog Number
- 8300014301
- Company Name
- Henke-Sass, Wolf GmbH
- Labeler DUNS
- 317326411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 5
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- cc2441cb-feb8-45e0-a280-47c59d1d7b1a
Device Description
HSW FINE-JECT® 0,8X10MM / 21GX3/8" STERILE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59230 | Hypodermic needle, single-use | A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04035873035787 | GS1 | CARTON | 30 | In Commercial Distribution | |
| Primary | 04035873035794 | GS1 | ||||
| Unit of Use | 04035873052678 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.8 | Millimeter | |
| Length | 10 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry