Delta Ceramic Femoral Head

GUDID 00822409034888

Femoral Head 36-12/14+6

Ortho Development Corporation

Coated hip femur prosthesis, modular
Primary Device ID00822409034888
NIH Device Record Key10b10d8d-6f4b-46d8-b96b-cd249f5ef6d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDelta Ceramic Femoral Head
Version Model Number136-3616
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 Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409034888 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-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 Date2016-08-16

On-Brand Devices [Delta Ceramic Femoral Head]

00822409034963Femoral Head 40-12/14-6
00822409034956Femoral Head 40-12/14-3
00822409034949Femoral Head 40-12/14+9
00822409034932Femoral Head 40-12/14+6
00822409034925Femoral Head 40-12/14+3
00822409034918Femoral Head 40-12/14+0
00822409034901Femoral Head 36-12/14-6
00822409034895Femoral Head 36-12/14-3
00822409034888Femoral Head 36-12/14+6
00822409034871Femoral Head 36-12/14+3
00822409034864Femoral Head 36-12/14+0
00822409034857Femoral Head 32-12/14-6
00822409034840Femoral Head 32-12/14-3
00822409034833Femoral Head 32-12/14+6
00822409034826Femoral Head 32-12/14+3
00822409034819Femoral Head 32-12/14+0
00822409034802Femoral Head 28-12/14-3
00822409034796Femoral Head 28-12/14+3
00822409034789Femoral Head 28-12/14+0

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