USTAR II Knee System - Distal femoral resection guide, 9mm - UNITED ORTHOPEDIC CORP.

Duns Number:656700556

Device Description: Distal femoral resection guide, 9mm

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More Product Details

Catalog Number

-

Brand Name

USTAR II Knee System

Version/Model Number

9315-2101

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

55bab35b-f88b-4848-a3ac-a6c2518ba2b2

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

February 18, 2020

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