MRV Controller Adaptor - Adaptor for MRV Contoller. - PLANER LIMITED

Duns Number:217190495

Device Description: Adaptor for MRV Contoller.

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More Product Details

Catalog Number

-

Brand Name

MRV Controller Adaptor

Version/Model Number

GDMRV-ADAPTOR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

For Single-Use

-

Prescription Use (Rx)

-

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

KSP

Product Code Name

Apparatus, Cell-Freezing And Reagents

Device Record Status

Public Device Record Key

78003e78-895f-4f30-8b54-ca39e783acae

Public Version Date

October 28, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PLANER LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 23