Duns Number:421272490
Device Description: Twist Lancets+Lancing Device
Catalog Number
-
Brand Name
Care Touch
Version/Model Number
HH-X-T, IC
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
-
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
QRK
Product Code Name
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Public Device Record Key
7982affd-f4f8-444c-9722-c57ea779c0b5
Public Version Date
August 22, 2022
Public Version Number
1
DI Record Publish Date
August 12, 2022
Package DI Number
20810011730346
Quantity per Package
2020
Contains DI Package
10810011730349
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner case