Catalog Number

50-601XL

Brand Name

Myosure XL for Fluent Device

Version/Model Number

50-601XL

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

K181974,K181974,K181974,K181974

Product Code

HIH

Product Code Name

HYSTEROSCOPE (AND ACCESSORIES)

Public Device Record Key

c44e5995-3a6a-4a59-aad5-644f7f2015a4

Public Version Date

April 09, 2019

Public Version Number

2

DI Record Publish Date

September 26, 2018

Package DI Number

45420045507655

Quantity per Package

1

Contains DI Package

25420045507651

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON