Catalog Number

50-501XL

Brand Name

MyoSure Tissue Removal Device

Version/Model Number

50-501XL

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

K142029,K142029,K142029

Product Code

HIH

Product Code Name

HYSTEROSCOPE (AND ACCESSORIES)

Public Device Record Key

75ffa581-fa1e-4766-aa86-de1744594e29

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 08, 2016

Package DI Number

35420045505098

Quantity per Package

3

Contains DI Package

25420045505091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX