Duns Number:966390890
Device Description: FreeStyle Lancing Device II
Catalog Number
71582
Brand Name
FreeStyle
Version/Model Number
71582
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
4170c61b-6922-4b0f-8409-e96e1e73a8b9
Public Version Date
April 02, 2018
Public Version Number
1
DI Record Publish Date
February 28, 2018
Package DI Number
30357599000661
Quantity per Package
100
Contains DI Package
00357599000660
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 |