Duns Number:169895245
Device Description: Kroger Twist Lancets 26g
Catalog Number
926101
Brand Name
Kroger
Version/Model Number
926101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
4a4d0d02-ac46-4225-894d-2ca48a28bc33
Public Version Date
December 09, 2019
Public Version Number
1
DI Record Publish Date
December 01, 2019
Package DI Number
MHC19261013
Quantity per Package
10
Contains DI Package
MHC19261012
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 184 |