Duns Number:006966006
Device Description: CENSITRAC READY KEYES CUTANEOUS PUNCH RND 4MM
Catalog Number
-
Brand Name
Sklar®
Version/Model Number
06-4144C
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
-
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
LRY
Product Code Name
PUNCH, SURGICAL
Public Device Record Key
c0909321-139d-4806-b81d-8caee00dfab0
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
August 24, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13420 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 881 |