FDA UDI
In Commercial Distribution
🇺🇸 United States
Droplet, Lancing Device
DI: 05907996090327
·
Model: n/a
·
HTL STREFA S A
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Droplet, Lancing Device
- Primary DI
- 05907996090327
- Version / Model
- n/a
- Catalog Number
- 9006
- Company Name
- HTL STREFA S A
- Labeler DUNS
- 422528088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-01
- Public Version
- 1
- Public Version Date
- 2019-11-11
- Public Version Status
- New
- Public Device Record Key
- 7ea9d88d-7913-454f-8c80-38e980f38ad3
Device Description
he Droplet Lncing Device is a convenient medical device for use with exchangeable lancets in order to collect capillary blood samples for glucose monitoring or other tests.
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
- Yes
- 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
- 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 |
|---|---|---|---|---|---|---|
| Primary | 05907996090327 | GS1 | ||||
| Package | 15907996090324 | GS1 | shipper | 40 | In Commercial Distribution |
Customer Contacts
- Phone
- +484227000010
- [email protected]