INSTRUMENT - TRIATHLON SOLID TIBIAL INSERT TRIAL - CR - Howmedica Osteonics Corp.

Duns Number:058311945

Device Description: TRIATHLON SOLID TIBIAL INSERT TRIAL - CR

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


More Product Details

Catalog Number

5530-T-011Y

Brand Name

INSTRUMENT

Version/Model Number

5530-T-011Y

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

HWT

Product Code Name

TEMPLATE

Device Record Status

Public Device Record Key

babede3c-903a-453f-aa96-3e861fb3ef0f

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

June 11, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOWMEDICA OSTEONICS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5091
2 A medical device with a moderate to high risk that requires special controls. 10216
3 A medical device with high risk that requires premarket approval 32