Enztec Patella Reamer Collet - S+N – 32 - 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

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More Product Details

Catalog Number

4240-4372

Brand Name

Enztec Patella Reamer Collet - S+N – 32

Version/Model Number

4240-4372

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

db2142cd-1ed8-4313-ae7c-1cd87c5c27bd

Public Version Date

December 10, 2021

Public Version Number

1

DI Record Publish Date

December 02, 2021

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