Duns Number:217266915
Device Description: Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm - sterile, single use safety Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm - sterile, single use safety lancet
Catalog Number
-
Brand Name
Unistik Touch
Version/Model Number
AT 1412
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"
Yes
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
51219eb4-c8a3-4591-a010-7c2d8ca930a4
Public Version Date
June 24, 2021
Public Version Number
2
DI Record Publish Date
April 02, 2021
Package DI Number
00384701412035
Quantity per Package
40
Contains DI Package
00384701412011
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 |