Catalog Number

57603

Brand Name

AMD-RITMED SOLON

Version/Model Number

57603

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

40a78df2-918e-4a2b-aa86-af93665cf663

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

January 14, 2019

Package DI Number

12686864046009

Quantity per Package

50

Contains DI Package

10686864046001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box