EXULT Knee Replacement System - Patella peg drill guide body #30 - Corentec Co., Ltd

Duns Number:688739895

Device Description: Patella peg drill guide body #30

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More Product Details

Catalog Number

-

Brand Name

EXULT Knee Replacement System

Version/Model Number

KA.SPC.0015-B3

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)

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

a9e010b9-6be1-4b7b-9bec-19b0f5e9a489

Public Version Date

December 18, 2020

Public Version Number

2

DI Record Publish Date

May 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORENTEC CO., LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 327
2 A medical device with a moderate to high risk that requires special controls. 8249