Catalog Number

0794-001-020

Brand Name

N/A

Version/Model Number

0794001020

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

-

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

-

Product Code

LWH

Product Code Name

Counter, sponge, surgical

Public Device Record Key

0b231d90-f229-4a59-98c5-6e791d073db6

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 17, 2020

Package DI Number

37613327509107

Quantity per Package

4

Contains DI Package

07613327509106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack