DUMI ManipulatOR - Diagnostic Uterine Manipulator Injector - THE O R COMPANY PTY LTD

Duns Number:744346235

Device Description: Diagnostic Uterine Manipulator Injector

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More Product Details

Catalog Number

-

Brand Name

DUMI ManipulatOR

Version/Model Number

DUMI-350A

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

20688f6e-8f65-4329-bc88-0166b04b5ea0

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

January 18, 2022

Additional Identifiers

Package DI Number

09349967001035

Quantity per Package

12

Contains DI Package

09349967001028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box

"THE O R COMPANY PTY LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 32