Duns Number:217266915
Device Description: Unistik 3 Dual 18G x 1.8mm, Sterile, single use safety lancet
Catalog Number
-
Brand Name
Unistik 3
Version/Model Number
AT1062
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
8444963c-1155-4894-9790-1ae2df55f754
Public Version Date
June 17, 2021
Public Version Number
2
DI Record Publish Date
September 12, 2019
Package DI Number
00384701062032
Quantity per Package
40
Contains DI Package
00384701062018
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 | 1 |