FDA UDI
In Commercial Distribution
🇺🇸 United States
droplet Genteel lancing device
DI: 05907996098774
·
Model: n/a
·
HTL STREFA S A
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- droplet Genteel lancing device
- Primary DI
- 05907996098774
- Version / Model
- n/a
- Catalog Number
- 9150
- Company Name
- HTL STREFA S A
- Labeler DUNS
- 422528088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-20
- Public Version
- 2
- Public Version Date
- 2021-10-01
- Public Version Status
- Update
- Public Device Record Key
- cdfd18a6-50f0-4029-b8fc-766d0e0d317b
Device Description
The Droplet Genteel Lancing Device is used with disposable lancets to draw capillary blood from the fingertip or alternate sites for glucose testing or other testing utilizing small amount of blood.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMK | Lancet, Blood | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37243 | Manual blood lancing device, reusable | A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15907996098771 | GS1 | shipper box | 24 | In Commercial Distribution | |
| Primary | 05907996098774 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153670 | 000 |