Catalog Number

-

Brand Name

PROXIMEL NON BORDER 8x8 5/BX

Version/Model Number

15713104

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

ccb60257-59c6-413e-ab7a-b0d201b0b954

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Package DI Number

20612553023678

Quantity per Package

5

Contains DI Package

10612553023671

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-