Duns Number:080028910
Device Description: Colored lancets. Silicone-coated lancets. Use with the MICROLET Family of lancing device
Catalog Number
81264857, 81264954 (US)
Brand Name
MICROLET®
Version/Model Number
6586 / 6586W
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)
-
Over the Counter (OTC)
Yes
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
55dfab27-fce9-4952-97fc-e7516661e22c
Public Version Date
June 14, 2019
Public Version Number
1
DI Record Publish Date
June 06, 2019
Package DI Number
40301936586124
Quantity per Package
12
Contains DI Package
00301936586218
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipper/case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |
| 3 | A medical device with high risk that requires premarket approval | 2 |