Kryo 560 Freezer - Kryo 560 Controlled Rate Freezer. 16 Litre Chamber - PLANER LIMITED

Duns Number:217190495

Device Description: Kryo 560 Controlled Rate Freezer. 16 Litre Chamber

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More Product Details

Catalog Number

-

Brand Name

Kryo 560 Freezer

Version/Model Number

GDKRYO560-16-115

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

22d1b7a3-a763-470c-b8d8-bcb08206a626

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