Duns Number:966390890
Device Description: Abbott SF Single Use Lancing Device
Catalog Number
70901
Brand Name
Abbott
Version/Model Number
70901
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 15, 2021
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
243021ce-0f42-407f-a2d3-958523fa47b6
Public Version Date
January 15, 2021
Public Version Number
3
DI Record Publish Date
June 15, 2018
Package DI Number
30357599000692
Quantity per Package
20
Contains DI Package
00357599000691
Package Discontinue Date
January 15, 2021
Package Status
Not 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 |