Duns Number:961027315
Device Description: ULTRA LOW FLOW SAFETY LANCET, 30G,
Catalog Number
SLULF100
Brand Name
CARDINAL HEALTH
Version/Model Number
SLULF100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
August 04, 2024
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)
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
57c769c1-5299-4dd5-9da8-12d123732cb7
Public Version Date
June 14, 2019
Public Version Number
2
DI Record Publish Date
April 12, 2019
Package DI Number
50885380065949
Quantity per Package
40
Contains DI Package
20885380065948
Package Discontinue Date
August 04, 2024
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 |