Orthinox 6364-2-228

GUDID 04546540273376

V40 FEM HEAD

Howmedica Osteonics Corp.

Metallic femoral head prosthesis
Primary Device ID04546540273376
NIH Device Record Key388726ba-1383-4a18-aac1-d142fab8ce8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthinox
Version Model Number6364-2-228
Catalog Number6364-2-228
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter28 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104546540273376 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-06
Device Publish Date2024-05-29

On-Brand Devices [Orthinox]

07613153122012V40 Femoral head
07613153122005V40 Femoral head
07613153121992V40 Femoral head
04546540402189V40 FEM HEAD
04546540402172V40 FEM HEAD
04546540402165V40 FEM HEAD
04546540402158V40 FEM HEAD
04546540273390V40 FEM HEAD
04546540273383V40 Femoral head
04546540273369V40 FEM HEAD
04546540273345V40 FEM HEAD
04546540273338V40 Femoral head
04546540273321V40 FEM HEAD
04546540273314V40 FEM HEAD
04546540273307V40 FEM HEAD
04546540273291V40 FEM HEAD
04546540273284V40 Femoral head
04546540273277V40 FEM HEAD
04546540273260V40 FEM HEAD
04546540273376V40 FEM HEAD

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