Catalog Number

-

Brand Name

Myotrac 3 Unit

Version/Model Number

SA9900

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K925681

Product Code

HIR

Product Code Name

Perineometer

Public Device Record Key

9a6e73b4-3b24-422c-883f-4df95816b04d

Public Version Date

November 20, 2019

Public Version Number

2

DI Record Publish Date

October 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-