TRIHA+ - TEKNIMED

Duns Number:764746723

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

T824505

Brand Name

TRIHA+

Version/Model Number

Granules 6x3x2 10cc

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 17, 2020

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

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

48bcbe10-74a0-476e-ac73-14e211303605

Public Version Date

November 26, 2020

Public Version Number

6

DI Record Publish Date

October 16, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEKNIMED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 96