ELITE PLUS 965228047

GUDID 10603295318644

ELITE PLUS Cup Flanged - CEMENTED LPW 28mmID 47mmOD

DEPUY (IRELAND)

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 10603295318644
• NIH Device Record Key: 547cb823-4388-4c3f-b964-40ca09eb5818
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELITE PLUS
• Version Model Number: 9652-28-047
• Catalog Number: 965228047
• 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
• 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	10603295318644 [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