RF Cable A1 - For connecting Double Pump RF to S&N Dyonics RF, - INSIGHTRA MEDICAL, INC.

Duns Number:097664937

Device Description: For connecting Double Pump RF to S&N Dyonics RF, ArthroCare Atlas, ArthroCare Quantum and

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More Product Details

Catalog Number

-

Brand Name

RF Cable A1

Version/Model Number

1402008

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K093409

Product Code Details

Product Code

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

2dd3ccf9-e8e7-4507-8f1e-8b4b550bba69

Public Version Date

May 27, 2021

Public Version Number

4

DI Record Publish Date

March 17, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSIGHTRA MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 36