Klassic Knee Case 1, Femoral Preparation Instrumentation - Knee Case 1, Femoral Preparation Instrumentation - TOTAL JOINT ORTHOPEDICS, INC.

Duns Number:078416717

Device Description: Knee Case 1, Femoral Preparation Instrumentation

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More Product Details

Catalog Number

-

Brand Name

Klassic Knee Case 1, Femoral Preparation Instrumentation

Version/Model Number

2405.00.000

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

610ab0a4-77eb-417e-a76e-26a46f06d01a

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

November 04, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOTAL JOINT ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 880
2 A medical device with a moderate to high risk that requires special controls. 732