Duns Number:531855211
Catalog Number
PRP-S32
Brand Name
JetPeel
Version/Model Number
Prestige Plus HP
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
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
GFE
Product Code Name
Brush, Dermabrasion, Powered
Public Device Record Key
eac941cf-d5c3-47cb-87d7-00dfb18fbd15
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
Package DI Number
07290014242364
Quantity per Package
5
Contains DI Package
07290014242937
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |