ELITE 962517000

GUDID 10603295318064

ELITE CUP OGEE - CEMENTED LPW 32mmID 47mmOD

DEPUY INTERNATIONAL LTD

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: 10603295318064
• NIH Device Record Key: 50e5ed95-1eba-4393-b070-28546a7aab44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELITE
• Version Model Number: 9625-17-000
• Catalog Number: 962517000
• Company DUNS: 896498813
• Company Name: DEPUY INTERNATIONAL LTD
• 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	10603295318064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940743

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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]

• 10603295128298: ELITE STEM INTRODUCER
• 10603295318088: ELITE CUP OGEE - CEMENTED LPW 32mmID 53mmOD
• 10603295318071: ELITE CUP OGEE - CEMENTED LPW 32mmID 50mmOD
• 10603295318064: ELITE CUP OGEE - CEMENTED LPW 32mmID 47mmOD
• 10603295243397: ELITE FEMORAL PROS HOLDER
• 10603295243380: ELITE SOCKET GAUGE FOR 53MM CUP
• 10603295243366: ELITE SOCKET GAUGE FOR 50MM CUP
• 10603295243342: ELITE SOCKET GAUGE FOR 47MM CUP