Duns Number:966390890
Device Description: FreeStyle Unistik 2
Catalog Number
70428
Brand Name
FreeStyle
Version/Model Number
70428
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)
-
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
de5ac188-4a67-46b4-8b3c-763fa36b5abe
Public Version Date
August 03, 2018
Public Version Number
1
DI Record Publish Date
July 03, 2018
Package DI Number
30093815704288
Quantity per Package
30
Contains DI Package
00093815704287
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 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 |