MOBIO™ Total Knee System - Tibial Baseplate Extractor - B-ONE ORTHO, CORP.

Duns Number:081315444

Device Description: Tibial Baseplate Extractor

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More Product Details

Catalog Number

8829216000

Brand Name

MOBIO™ Total Knee System

Version/Model Number

8829216000

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

HWB

Product Code Name

Extractor

Device Record Status

Public Device Record Key

0158e1cf-d3e5-43ed-87bc-25f30a836118

Public Version Date

June 03, 2019

Public Version Number

1

DI Record Publish Date

May 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B-ONE ORTHO, CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 273
2 A medical device with a moderate to high risk that requires special controls. 707