Catalog Number

4001D

Brand Name

AMD-RITMED SOLON PURFYBR

Version/Model Number

4001D

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

f5c13ecb-d86c-409b-8868-293ed997717c

Public Version Date

October 14, 2021

Public Version Number

4

DI Record Publish Date

January 14, 2019

Package DI Number

12686864048409

Quantity per Package

100

Contains DI Package

10686864048401

Package Discontinue Date

October 13, 2021

Package Status

Not in Commercial Distribution

Package Type

Inner Box