Solitude Unipolar

GUDID 00822409015009

58mm Unipolar

Ortho Development Corporation

Femoral head/stem prosthesis adaptor
Primary Device ID00822409015009
NIH Device Record Key9cd861b5-eb5d-4d3c-971e-1e5be8647f04
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolitude Unipolar
Version Model Number132-0058
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

Device Dimensions

Outer Diameter58 Millimeter
Outer Diameter58 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409015009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWLProsthesis, hip, hemi-, femoral, metal

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 [Solitude Unipolar]

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00822409015061+9mm 12/14 Offset Adapter
00822409015054+6mm 12/14 Offset Adapter
00822409015047+3mm 12/14 Offset Adapter
00822409015030+0mm 12/14 Offset Adapter
0082240901502360mm Unipolar
0082240901501659mm Unipolar
0082240901500958mm Unipolar
0082240901499657mm Unipolar
0082240901498956mm Unipolar
0082240901497255mm Unipolar
0082240901496554mm Unipolar
0082240901495853mm Unipolar
0082240901494152mm Unipolar
0082240901493451mm Unipolar
0082240901492750mm Unipolar
0082240901491049mm Unipolar
0082240901490348mm Unipolar
0082240901489747mm Unipolar
0082240901488046mm Unipolar
0082240901487345mm Unipolar
0082240901486644mm Unipolar
0082240901485943mm Unipolar
0082240901484242mm Unipolar
0082240901483541mm Unipolar
0082240901482840mm Unipolar
0082240901481139mm Unipolar
0082240901480438mm Unipolar

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