Paxeon BiPolar Head - Bipolar Head Size 28/56 - PAXEON RECONSTRUCTION LLC

Duns Number:080437990

Device Description: Bipolar Head Size 28/56

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More Product Details

Catalog Number

-

Brand Name

Paxeon BiPolar Head

Version/Model Number

PR111-21-2856

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

K133370

Product Code Details

Product Code

KWY

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Device Record Status

Public Device Record Key

63c06698-56c6-4a6a-908d-10edff8dc29b

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

December 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PAXEON RECONSTRUCTION LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 205