Catalog Number

MIS-50P

Brand Name

TVUS/HSG-Cath

Version/Model Number

Peel-Away Introducer

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

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

K063611,K063611

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

344fc012-90e2-43b5-8cc6-39391a2d38d2

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

H671MIS50P1

Quantity per Package

10

Contains DI Package

H671MIS50P0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box