Kit SST-R HD 60 cm - Kit SST-R HD for the retrofitting shelves of - BIOLOG-ID

Duns Number:277828187

Device Description: Kit SST-R HD for the retrofitting shelves of refrigerator 60cm

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More Product Details

Catalog Number

-

Brand Name

Kit SST-R HD 60 cm

Version/Model Number

01

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

KSE

Product Code Name

Refrigerator, Freezer, Blood Storage

Device Record Status

Public Device Record Key

836acb9e-6731-484e-b788-020b2218e4bc

Public Version Date

October 28, 2021

Public Version Number

1

DI Record Publish Date

October 20, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOLOG-ID" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12