ELITE PLUS 965128047

GUDID 10603295318545

ELITE PLUS Cup - CEMENTED LPW 28mmID 47mmOD

DEPUY (IRELAND)

Acetabular shell

• Primary Device ID: 10603295318545
• NIH Device Record Key: efed24e1-3985-49b0-9e7c-27ec8f16e93e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELITE PLUS
• Version Model Number: 9651-28-047
• Catalog Number: 965128047
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295318545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K871867

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-09-24

On-Brand Devices [ELITE PLUS]

• 10603295318859: ELITE PLUS CUP OGEE - CEMENTED LPW 28mmID 53mmOD
• 10603295318842: ELITE PLUS CUP OGEE - CEMENTED LPW 28mmID 50mmOD
• 10603295318835: ELITE PLUS CUP OGEE - CEMENTED LPW 28mmID 47mmOD
• 10603295318828: ELITE PLUS CUP OGEE - CEMENTED LPW 28mmID 43mmOD
• 10603295318811: ELITE PLUS CUP OGEE - CEMENTED LPW 28mmID 40mmOD
• 10603295318804: ELITE PLUS CUP OGEE - CEMENTED LPW 26mmID 53mmOD
• 10603295318798: ELITE PLUS CUP OGEE - CEMENTED LPW 26mmID 50mmOD
• 10603295318781: ELITE PLUS CUP OGEE - CEMENTED LPW 26mmID 47mmOD
• 10603295318774: ELITE PLUS CUP OGEE - CEMENTED LPW 26mmID 43mmOD
• 10603295318767: ELITE PLUS CUP OGEE - CEMENTED LPW 26mmID 40mmOD
• 10603295318668: ELITE PLUS Cup Flanged - CEMENTED LPW 28mmID 53mmOD
• 10603295318651: ELITE PLUS Cup Flanged - CEMENTED LPW 28mmID 50mmOD
• 10603295318644: ELITE PLUS Cup Flanged - CEMENTED LPW 28mmID 47mmOD
• 10603295318637: ELITE PLUS Cup Flanged - CEMENTED LPW 28mmID 43mmOD
• 10603295318620: ELITE PLUS Cup Flanged - CEMENTED LPW 28mmID 40mmOD
• 10603295318569: ELITE PLUS Cup - CEMENTED LPW 28mmID 53mmOD
• 10603295318552: ELITE PLUS Cup - CEMENTED LPW 28mmID 50mmOD
• 10603295318545: ELITE PLUS Cup - CEMENTED LPW 28mmID 47mmOD
• 10603295318538: ELITE PLUS Cup - CEMENTED LPW 28mmID 43mmOD
• 10603295318521: ELITE PLUS Cup - CEMENTED LPW 28mmID 40mmOD