Paxeon Logical - Logical G-Series Shell – 3 Holes Size 66-E - PAXEON RECONSTRUCTION LLC

Duns Number:080437990

Device Description: Logical G-Series Shell – 3 Holes Size 66-E

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Paxeon Logical

Version/Model Number

PR111-12-3366

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

K121297

Product Code Details

Product Code

LPH

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Device Record Status

Public Device Record Key

058f5b2b-7fd0-4487-a34a-aa8fb15a8f39

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