Duns Number:303639066
Device Description: MiniCollect® Lancelino Safety Lancet penetration depth 2.00 mm yellow, sterile, for capill MiniCollect® Lancelino Safety Lancet penetration depth 2.00 mm yellow, sterile, for capillary blood collection with blade, width 0.8 mm
Catalog Number
450524
Brand Name
MiniCollect
Version/Model Number
450524
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
7629bd78-b5b5-4968-a141-75f1e3f24f7e
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
39120049202240
Quantity per Package
10
Contains DI Package
29120049202243
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 |