PowerPumpTM dp System Interface Cable, Type 1 - Compatible with: S&N Dyonics Power, Dyonics Power - INSIGHTRA MEDICAL, INC.

Duns Number:097664937

Device Description: Compatible with: S&N Dyonics Power, Dyonics Power 2

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More Product Details

Catalog Number

-

Brand Name

PowerPumpTM dp System Interface Cable, Type 1

Version/Model Number

941037G

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

21027834-9b59-4901-9efe-ce21e455020c

Public Version Date

May 27, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

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