4mm Plug x 5M Monopolar Cable Reusable - 4mm Plug x 3M Monopolar Cable Reusable4mm Plug x - ORANGE SURGICAL INSTRUMENTS, LLC

Duns Number:047063695

Device Description: 4mm Plug x 3M Monopolar Cable Reusable4mm Plug x 5M Monopolar Cable Reusable

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More Product Details

Catalog Number

OS-MCR-4mm x 5MR

Brand Name

4mm Plug x 5M Monopolar Cable Reusable

Version/Model Number

OS-MCR-4mm x 5MR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2019

Issuing Agency

In HIBCC

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)

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

caa254ac-08de-4a76-8b7b-5ecd00bd5c9a

Public Version Date

November 15, 2019

Public Version Number

3

DI Record Publish Date

November 15, 2016

Additional Identifiers

Package DI Number

B354OSMCR4MMX5MR10

Quantity per Package

10

Contains DI Package

B354OSMCR4MMX5MR0

Package Discontinue Date

November 15, 2019

Package Status

Not in Commercial Distribution

Package Type

-

"ORANGE SURGICAL INSTRUMENTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 271