Duns Number:422528088
Device Description: Medlance, safety lancets are sterile, single use medical devices intended for capillary b Medlance, safety lancets are sterile, single use medical devices intended for capillary blood sampling.
Catalog Number
7001
Brand Name
Medlance, safety lancet
Version/Model Number
21G 1.8mm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
49602ebc-7f99-4e07-b8c5-de151e6c8003
Public Version Date
August 13, 2021
Public Version Number
3
DI Record Publish Date
August 15, 2020
Package DI Number
15907506237027
Quantity per Package
6
Contains DI Package
05907506237020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |