PowerPumpTM dp System Patient tubing - INSIGHTRA MEDICAL, INC.

Duns Number:097664937

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More Product Details

Catalog Number

-

Brand Name

PowerPumpTM dp System Patient tubing

Version/Model Number

941014

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

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

K093409,K093409

Product Code Details

Product Code

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

898721c8-b4d6-4d93-bacf-9ee75fdea9f4

Public Version Date

May 27, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

17350021987058

Quantity per Package

10

Contains DI Package

17350021986143

Package Discontinue Date

-

Package Status

In Commercial Distribution

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