CoCr Femoral Head

GUDID 00822409033102

12/14 CoCr Femoral Head 40 mm -9

Ortho Development Corporation

Acetabular shell
Primary Device ID00822409033102
NIH Device Record Key16f2058b-e4bf-4728-9516-87d889679800
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoCr Femoral Head
Version Model Number138-4090
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 Producttrue
Device Kittrue
Device Combination Producttrue
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

Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409033102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS 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 Date2016-07-27

On-Brand Devices [CoCr Femoral Head]

0082240903310212/14 CoCr Femoral Head 40 mm -9
0082240903309612/14 CoCr Femoral Head 36 mm -9
0082240903308912/14 CoCr Femoral Head 32 mm -8

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