Catalog Number

66801237

Brand Name

REPLICaRE THIN4X4"(10X10CM)

Version/Model Number

66801237

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)

-

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

a37b5a42-15c3-4fd3-b064-52e5613652a6

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

October 07, 2020

Package DI Number

05000223480646

Quantity per Package

10

Contains DI Package

05000223480639

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton