Catalog Number

A3301

Brand Name

AMD-RITMED TOP

Version/Model Number

A3301

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)

-

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

5cc3ad90-c944-49df-aea6-0df2f39118c6

Public Version Date

April 23, 2019

Public Version Number

2

DI Record Publish Date

January 24, 2019

Package DI Number

20686864050845

Quantity per Package

40

Contains DI Package

10686864050848

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case