Hang&Go - Kit for Hyperthermic Perfusion - RAND SPA

Duns Number:655010531

Device Description: Kit for Hyperthermic Perfusion

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More Product Details

Catalog Number

R9900120

Brand Name

Hang&Go

Version/Model Number

001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 23, 2020

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"

Yes

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

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

6c2faa08-ecaa-4999-8dca-a72722db9220

Public Version Date

July 24, 2020

Public Version Number

2

DI Record Publish Date

April 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RAND SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10