Duns Number:787828537
Device Description: Polyethylene and stainless steel. Fine gauge, tri-bevel tip for virtually painless smaplin Polyethylene and stainless steel. Fine gauge, tri-bevel tip for virtually painless smapling. Universal Design. Fits almost all lancing devices.
Catalog Number
-
Brand Name
ViaMed
Version/Model Number
13013
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)
-
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
7e8a426a-1f79-4fd5-a8ea-7dae160e2f00
Public Version Date
September 30, 2020
Public Version Number
1
DI Record Publish Date
September 22, 2020
Package DI Number
00811382010606
Quantity per Package
50
Contains DI Package
00811382015595
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |