ManipulatOR - Uterine Manipulator - SURGI SUPPLIES INTERNATIONAL PTY. LTD.

Duns Number:753476779

Device Description: Uterine Manipulator

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More Product Details

Catalog Number

UM-TV

Brand Name

ManipulatOR

Version/Model Number

UM-TV

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"

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

-

Product Code Details

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Device Record Status

Public Device Record Key

1845dc43-5913-4416-831e-5cfe06f611ff

Public Version Date

December 07, 2018

Public Version Number

3

DI Record Publish Date

November 09, 2016

Additional Identifiers

Package DI Number

09349967000021

Quantity per Package

6

Contains DI Package

09349967000014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box

"SURGI SUPPLIES INTERNATIONAL PTY. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4