Catalog Number

JBPH-001

Brand Name

JetPeel

Version/Model Number

BiPhasic 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

-

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

23fa4d4d-515b-434c-b285-d8d841f6e386

Public Version Date

November 06, 2019

Public Version Number

1

DI Record Publish Date

October 29, 2019

Package DI Number

07290014242074

Quantity per Package

4

Contains DI Package

07290014242715

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-