Catalog Number

66000434

Brand Name

REPLICaRE ULTRa 10X10CM CTN 10

Version/Model Number

66000434

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

0b3abd42-2e0b-4e7e-8047-3c80c77a8582

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

October 07, 2020

Package DI Number

05000223437770

Quantity per Package

10

Contains DI Package

05000223437732

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton