Patellar thickness gauge, 9mm, M - U2 Total Knee System - UNITED ORTHOPEDIC CORP.

Duns Number:656700556

Device Description: U2 Total Knee System

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More Product Details

Catalog Number

9403-7109

Brand Name

Patellar thickness gauge, 9mm, M

Version/Model Number

9403-7109

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)

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

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

bb968770-a49c-4852-aad0-f38dddf71a6f

Public Version Date

August 23, 2018

Public Version Number

1

DI Record Publish Date

July 23, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UNITED ORTHOPEDIC CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1150
2 A medical device with a moderate to high risk that requires special controls. 4885