Catalog Number

-

Brand Name

MYOSURE XL HYSTEROSCOPY SET

Version/Model Number

50-250XL

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K122563

Product Code

HIH

Product Code Name

HYSTEROSCOPE (AND ACCESSORIES)

Public Device Record Key

c28cd9b1-2869-4b3c-abca-224482adff67

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

October 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-