Patella Drill Guide - Medacta - A reusable manual surgical instrument intended to - ENZTEC LIMITED

Duns Number:592616445

Device Description: A reusable manual surgical instrument intended to be used during an orthopaedic surgical p A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

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


More Product Details

Catalog Number

4240-4090

Brand Name

Patella Drill Guide - Medacta

Version/Model Number

4240-4090

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)

-

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

FZX

Product Code Name

Guide, Surgical, Instrument

Device Record Status

Public Device Record Key

9c302761-e685-482a-a53c-dde7ff3ed9f7

Public Version Date

June 14, 2022

Public Version Number

1

DI Record Publish Date

June 06, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENZTEC LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 107
2 A medical device with a moderate to high risk that requires special controls. 7