Duns Number:783518983
Device Description: ZevRx Twist Top Lancets 30G100 Sterile-tip lancets per boxSingle-use lancetsVirtually pain ZevRx Twist Top Lancets 30G100 Sterile-tip lancets per boxSingle-use lancetsVirtually painless testingControlled depth penetrationSmooth tri-bevel pointFits most lancing devices
Catalog Number
-
Brand Name
ZevRx Twist Top Lancets 30G
Version/Model Number
1
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
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Public Device Record Key
d73060e5-83c3-41d3-b02a-08833eda5fdb
Public Version Date
August 24, 2022
Public Version Number
1
DI Record Publish Date
August 16, 2022
Package DI Number
10850632007765
Quantity per Package
200
Contains DI Package
00850632007768
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |