Catalog Number

56122

Brand Name

AMD-RITMED SOLON

Version/Model Number

56122

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

KXF

Product Code Name

APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Public Device Record Key

5c32966c-ebb1-49e0-84c1-b91387e3d0ef

Public Version Date

February 11, 2022

Public Version Number

2

DI Record Publish Date

January 14, 2019

Package DI Number

12686864049055

Quantity per Package

10

Contains DI Package

10686864049057

Package Discontinue Date

February 10, 2022

Package Status

Not in Commercial Distribution

Package Type

Inner Box