Catalog Number

20-401ML

Brand Name

Myosure Manual Tissue Removal Device

Version/Model Number

20-401ML

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NWW

Product Code Name

Hysteroscope accessories

Public Device Record Key

b59338aa-6ad5-435d-9913-02af30a8f13a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 08, 2018

Package DI Number

35420045507931

Quantity per Package

1

Contains DI Package

25420045507934

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX