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 Twist Top Lancets 30G
Version/Model Number
PureCSafety30
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
b2f0236f-d168-440f-9879-a6415fe2a0da
Public Version Date
March 05, 2020
Public Version Number
1
DI Record Publish Date
February 26, 2020
Package DI Number
10860003125561
Quantity per Package
100
Contains DI Package
00860003125564
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 |