Catalog Number

55600

Brand Name

AMD-RITMED SOLON

Version/Model Number

55600

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

FMA

Product Code Name

DEPRESSOR, TONGUE, NON-SURGICAL

Public Device Record Key

8e93be6d-6ec8-480a-a4c3-d00782a2d26e

Public Version Date

October 14, 2021

Public Version Number

2

DI Record Publish Date

January 16, 2019

Package DI Number

12686864048867

Quantity per Package

250

Contains DI Package

10686864048869

Package Discontinue Date

October 13, 2021

Package Status

Not in Commercial Distribution

Package Type

Inner Box