Valtchev Uterine Mobilizer - THE VALTCHEV® UTERINE MOBILIZER, MODEL VUM-6 - Conkin Surgical Instruments Ltd

Duns Number:257261032

Device Description: THE VALTCHEV® UTERINE MOBILIZER, MODEL VUM-6 consists of a body and interchangeable obtura THE VALTCHEV® UTERINE MOBILIZER, MODEL VUM-6 consists of a body and interchangeable obturators and cannulas. The body consists of a metal bar and a metal tube which pivot the head. One end of the tube is attached to a piston and the opposite end is attached to a Luer syringe connector. The locking wheel is also attached to the tube. The locking wheel is held in place by a lock. The arm space bar permits manipulation of the head. By means of alocking screw on the upper end of the arm space bar the Mobilizer can be locked in the desired position. The finger ring is located at the lower end of the arm spacer bar. The head accommodates, in its cavity, an obturator or a cannula locking in place by a lock. The four uterine obturators, which are of different lengths and thicknesses are used as follows: No.17 and No.18 are for mobilization of a smaller uterus, No.19 and No.20 are for mobilization of larger uterus. The cannulas: (15A) and (16A) are used for injection of either dye or an X-ray contrast medium. The syringe for injection is attached to the Luer syringe connector. The Mobilizer is held in place by a Valtchev® tenaculum, supported by a tenaculum holder and held taut by a spring. This device is reusable. The attachments have no stand alone functionality, however can be ordered separately.

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More Product Details

Catalog Number

VUM-6

Brand Name

Valtchev Uterine Mobilizer

Version/Model Number

VUM-6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Device Record Status

Public Device Record Key

5ed245cf-c7aa-46af-9b52-bb3f58eef384

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10627843701788

Quantity per Package

1

Contains DI Package

00627843701781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"CONKIN SURGICAL INSTRUMENTS LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10