Catalog Number

57502

Brand Name

AMD-RITMED SOLON

Version/Model Number

57502

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

KXF

Product Code Name

APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Public Device Record Key

1ae7ccf5-6fd5-4d32-82ad-2b3f4a20ab33

Public Version Date

May 03, 2022

Public Version Number

2

DI Record Publish Date

January 14, 2019

Package DI Number

20686864046077

Quantity per Package

10

Contains DI Package

10686864046070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case