Duns Number:961027315
Device Description: LANCET SAFETY LOW FLOW NEEDLE GAUGE
Catalog Number
SLLF200
Brand Name
CARDINAL HEALTH
Version/Model Number
SLLF200
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"
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
e9820bf0-62d0-4172-8359-952f35a204d7
Public Version Date
April 01, 2022
Public Version Number
2
DI Record Publish Date
April 12, 2019
Package DI Number
50885380025820
Quantity per Package
20
Contains DI Package
20885380025829
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 | 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 |