Catalog Number

1089

Brand Name

ChitoGauze®XR PRO 3" x 4 yds Prometheus

Version/Model Number

1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102546,K102546

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

7c2f45a7-be42-4891-b5d7-9a3a04f1c2f3

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

January 27, 2021

Package DI Number

50870053000013

Quantity per Package

50

Contains DI Package

00870053000018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case