Liquid Scope HelpOR II - THE O R COMPANY PTY LTD

Duns Number:744346235

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More Product Details

Catalog Number

-

Brand Name

Liquid Scope HelpOR II

Version/Model Number

LSH-02

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

NWV

Product Code Name

Laparoscopic Accessories, Gynecologic

Device Record Status

Public Device Record Key

87c6ea37-fa93-4ec9-b767-f178f883d078

Public Version Date

March 17, 2022

Public Version Number

1

DI Record Publish Date

March 09, 2022

Additional Identifiers

Package DI Number

09349967004876

Quantity per Package

10

Contains DI Package

09349967004869

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner 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