Duns Number:961027315
Device Description: LANCET SAFETY LOW FLOW NEEDLE GAUGE
Catalog Number
SLLF100
Brand Name
CARDINAL HEALTH
Version/Model Number
SLLF100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 08, 2023
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"
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
88df330d-1562-4110-830b-3feaf2c025ed
Public Version Date
October 24, 2019
Public Version Number
2
DI Record Publish Date
April 12, 2019
Package DI Number
50885380025813
Quantity per Package
40
Contains DI Package
20885380025812
Package Discontinue Date
October 08, 2023
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |