Catalog Number

4001DS

Brand Name

AMD-RITMED SOLON PURFYBR

Version/Model Number

4001DS

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

KXG

Product Code Name

APPLICATOR, ABSORBENT TIPPED, STERILE

Public Device Record Key

9f1c4ab0-5524-4ea9-8c82-ae4b197fa9bf

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

January 14, 2019

Package DI Number

20686864048415

Quantity per Package

10

Contains DI Package

12686864048416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case