Bipolar Heads

GUDID 07630030843617

Ø28x45

Medacta International SA

Femoral head bipolar component
Primary Device ID07630030843617
NIH Device Record Key32828030-a80e-4c40-bb62-b2aa15ab47ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameBipolar Heads
Version Model Number25060.2845
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630030843617 [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 Date2014-11-18

On-Brand Devices [Bipolar Heads]

07630030843914Ø28x60
07630030843891Ø28x59
07630030843877Ø28x58
07630030843853Ø28x57
07630030843839Ø28x56
07630030843815Ø28x55
07630030843792Ø28x54
07630030843778Ø28x53
07630030843754Ø28x52
07630030843730Ø28x51
07630030843716Ø28x50
07630030843693Ø28x49
07630030843679Ø28x48
07630030843655Ø28x47
07630030843631Ø28x46
07630030843617Ø28x45
07630030843594Ø28x44
07630030843532Ø22x52
07630030843518Ø22x51
07630030843495Ø22x50
07630030843471Ø22x49
07630030843457Ø22x48
07630030843433Ø22x47
07630030843419Ø22x46
07630030843396Ø22x45
07630030843372Ø22x44
07630030843358Ø22x43
07630030843334Ø22x42
07630030843310Ø22x41
07630030843297Ø22x40

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