Button Holder - Intended to be used for the preparation and - ENZTEC LIMITED

Duns Number:592616445

Device Description: Intended to be used for the preparation and pre-tensioning of single tendon grafts for lig Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction

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


More Product Details

Catalog Number

72205273

Brand Name

Button Holder

Version/Model Number

72205273

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

83df6f4f-dd27-44ee-ad2f-b4b2e2f3ce66

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

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