PowerPumpTM dp System Power Pump dp HP Interface Box Type 4 - INSIGHTRA MEDICAL, INC.

Duns Number:097664937

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More Product Details

Catalog Number

-

Brand Name

PowerPumpTM dp System Power Pump dp HP Interface Box Type 4

Version/Model Number

941025G

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

db24bb65-53f7-4c8e-88ce-fe3caef88421

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