Catalog Number

56800

Brand Name

AMD-RITMED SOLON

Version/Model Number

56800

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

060a0bcb-2bde-428c-99f9-c51c19631bdc

Public Version Date

February 11, 2022

Public Version Number

4

DI Record Publish Date

January 14, 2019

Package DI Number

12686864049116

Quantity per Package

100

Contains DI Package

10686864049118

Package Discontinue Date

February 10, 2022

Package Status

Not in Commercial Distribution

Package Type

Inner Box