Catalog Number

-

Brand Name

Wound-Care

Version/Model Number

WC9012231

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Public Device Record Key

5e92a534-6b34-4615-abd6-56a9370cfb9c

Public Version Date

December 29, 2020

Public Version Number

1

DI Record Publish Date

December 21, 2020

Package DI Number

G018WC90122312

Quantity per Package

25

Contains DI Package

G018WC90122311

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case