Duns Number:801895244
Device Description: Disposa-Derm® Skin Biopsy Punches Sample Set1 each: 2 mm, 3 mm, 4 mm, 5 mm, 6 mm
Catalog Number
-
Brand Name
Disposa-Derm® Skin Biopsy Punches Sample Set
Version/Model Number
5-PC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EME
Product Code Name
Punch, Biopsy, Surgical
Public Device Record Key
12a216d1-9929-4c35-a668-38f9bad8480a
Public Version Date
December 21, 2018
Public Version Number
3
DI Record Publish Date
June 15, 2017
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |