Duns Number:963856096
Device Description: Five inch Manual Dermatome (Drum and Stand Only), 5X8 Inch Size. (12.5 X 20 cm)(Large)
Catalog Number
35391015
Brand Name
Integra® Padgett® Dermatomes
Version/Model Number
35391015
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GFD
Product Code Name
DERMATOME
Public Device Record Key
fab237b5-8a29-4722-9ccd-9296a02fba58
Public Version Date
June 22, 2021
Public Version Number
3
DI Record Publish Date
February 23, 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 | 1079 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2066 |