Pivot Bipolar

GUDID 00822409015160

22x47mm Bipolar

Ortho Development Corporation

Femoral head bipolar component
Primary Device ID00822409015160
NIH Device Record Keyf01e856f-9513-417c-bd84-aa5d6e698db6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePivot Bipolar
Version Model Number133-2247
Company DUNS876542390
Company NameOrtho Development Corporation
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com

Device Dimensions

Lumen/Inner Diameter22 Millimeter
Lumen/Inner Diameter22 Millimeter
Lumen/Inner Diameter22 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter
Outer Diameter47 Millimeter
Lumen/Inner Diameter22 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409015160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-31

On-Brand Devices [Pivot Bipolar]

0082240901544328x60mm Bipolar
0082240901543628x59mm Bipolar
0082240901542928x58mm Bipolar
0082240901541228x57mm Bipolar
0082240901540528x56mm Bipolar
0082240901539928x55mm Bipolar
0082240901538228x54mm Bipolar
0082240901537528x53mm Bipolar
0082240901536828x52mm Bipolar
0082240901535128x51mm Bipolar
0082240901534428x50mm Bipolar
0082240901533728x49mm Bipolar
0082240901532028x48mm Bipolar
0082240901531328x47mm Bipolar
0082240901530628x46mm Bipolar
0082240901529022x60mm Bipolar
0082240901528322x59mm Bipolar
0082240901527622x58mm Bipolar
0082240901526922x57mm Bipolar
0082240901525222x56mm Bipolar
0082240901524522x55mm Bipolar
0082240901523822x54mm Bipolar
0082240901522122x53mm Bipolar
0082240901521422x52mm Bipolar
0082240901520722x51mm Bipolar
0082240901519122x50mm Bipolar
0082240901518422x49mm Bipolar
0082240901517722x48mm Bipolar
0082240901516022x47mm Bipolar
0082240901515322x46mm Bipolar
0082240901514622x45mm Bipolar
0082240901513922x44mm Bipolar
0082240901512222x43mm Bipolar
0082240901511522x42mm Bipolar
0082240901510822x41mm Bipolar
0082240901509222x39mm Bipolar
0082240901508522x38mm Bipolar
0082240901022622x40mm Bipolar

Trademark Results [Pivot Bipolar]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PIVOT BIPOLAR
PIVOT BIPOLAR
78594846 3294843 Live/Registered
Ortho Development Corporation
2005-03-24

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