Revision Cannula - Revision Cannula is intended to be used to distal - TECRES SPA

Duns Number:435428396

Device Description: Revision Cannula is intended to be used to distal femoral bone cement delivery through Tec Revision Cannula is intended to be used to distal femoral bone cement delivery through Tecres' Cemex System.

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


More Product Details

Catalog Number

-

Brand Name

Revision Cannula

Version/Model Number

ASA0050

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

Yes

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

KDD

Product Code Name

Kit, Surgical Instrument, Disposable

Device Record Status

Public Device Record Key

68d44bb7-748d-4c5a-83b6-af7502984430

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TECRES SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 52