Klassic HD Hip Case 2, Acetabular Instruments - Hip Case 2, Acetabular Instruments - TOTAL JOINT ORTHOPEDICS, INC.

Duns Number:078416717

Device Description: Hip Case 2, Acetabular Instruments

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More Product Details

Catalog Number

-

Brand Name

Klassic HD Hip Case 2, Acetabular Instruments

Version/Model Number

1406.00.000

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

OJH

Product Code Name

Orthopedic tray

Device Record Status

Public Device Record Key

a5383a5d-aaae-4252-8bc1-e08f0668d42a

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

October 23, 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