Duns Number:303639066
Device Description: MiniCollect® Lancelino Safety Lancet 25G penetration depth 1,50 mm lavender, sterile, for MiniCollect® Lancelino Safety Lancet 25G penetration depth 1,50 mm lavender, sterile, for capillary blood collection with needle
Catalog Number
450521
Brand Name
MiniCollect
Version/Model Number
450521
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
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
3650d79d-8dd5-4438-a4e5-84b993118a12
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
39120049202219
Quantity per Package
10
Contains DI Package
29120049202212
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |