TriniLIZE™ Stabilyte tubes - TCOAG IRELAND LIMITED

Duns Number:985039126

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More Product Details

Catalog Number

-

Brand Name

TriniLIZE™ Stabilyte tubes

Version/Model Number

T6006

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2019

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

-

Product Code Details

Product Code

KDT

Product Code Name

Container, Specimen Mailer And Storage, Sterile

Device Record Status

Public Device Record Key

b493f84a-cbb1-46a0-9fbc-b9297e2b90c1

Public Version Date

July 19, 2019

Public Version Number

3

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TCOAG IRELAND LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 19