Duns Number:783518983
Device Description: One handed useNo lancing device requiredAutomatic needle retractionLock out after use prev One handed useNo lancing device requiredAutomatic needle retractionLock out after use prevents needle stick injuries as well as cross-contamination
Catalog Number
-
Brand Name
Pure Comfort Safety Lancets 30G 50 count
Version/Model Number
PureCSafety50
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"
-
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
d6a550cf-0ad8-4ed5-9244-e843a47981a9
Public Version Date
April 01, 2021
Public Version Number
1
DI Record Publish Date
March 24, 2021
Package DI Number
10860006377813
Quantity per Package
100
Contains DI Package
00860006377816
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |