Duns Number:194550042
Device Description: CA40975 Skin Punch Biopsy Kit for Arkana Lab Only
Catalog Number
CA40975
Brand Name
Aero-Med
Version/Model Number
CA40975
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
KDD
Product Code Name
Kit, surgical instrument, disposable
Public Device Record Key
5dce540b-bd12-4199-9a6d-6d3aa80e7d4b
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
November 03, 2021
Package DI Number
50885380189362
Quantity per Package
30
Contains DI Package
10885380189364
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 | 467 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |