Catalog Number

59484600

Brand Name

REPLICaRE ULTRa DRS 4X4IN

Version/Model Number

59484600

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

1bd43d27-4105-4231-805a-33896509b15c

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

October 07, 2020

Package DI Number

00040565120713

Quantity per Package

5

Contains DI Package

00040565120706

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton