SELF CENTERING 103561000

GUDID 10603295003496

SELF CENTERING BI-POLAR HEAD 28mm ID 61mm OD

DEPUY ORTHOPAEDICS, INC.

Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 10603295003496
• NIH Device Record Key: 9d4d9315-81d9-4046-b352-e0d9b76f0f6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SELF CENTERING
• Version Model Number: 1035-61-000
• Catalog Number: 103561000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• 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	10603295003496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K812672

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

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 [SELF CENTERING]

• 10603295084495: SELF CENTERING MODULAR CATHCART TRIAL ADAPTOR REMOVER
• 10603295084488: SELF CENTERING MODULAR CATHCART HANDLE ANGLED
• 10603295084471: SELF CENTERING MODULAR CATHCART HANDLE STRAIGHT
• 10603295003700: SELF CENTERING BI-POLAR HEAD 22.225mm ID 57mm OD
• 10603295003694: SELF CENTERING BI-POLAR HEAD 22.225mm ID 56mm OD
• 10603295003687: SELF CENTERING BI-POLAR HEAD 22.225mm ID 55mm OD
• 10603295003670: SELF CENTERING BI-POLAR HEAD 22.225mm ID 54mm OD
• 10603295003663: SELF CENTERING BI-POLAR HEAD 22.225mm ID 53mm OD
• 10603295003656: SELF CENTERING BI-POLAR HEAD 22.225mm ID 52mm OD
• 10603295003649: SELF CENTERING BI-POLAR HEAD 22.225mm ID 51mm OD
• 10603295003632: SELF CENTERING BI-POLAR HEAD 22.225mm ID 50mm OD
• 10603295003625: SELF CENTERING BI-POLAR HEAD 22.225mm ID 49mm OD
• 10603295003618: SELF CENTERING BI-POLAR HEAD 22.225mm ID 48mm OD
• 10603295003601: SELF CENTERING BI-POLAR HEAD 22.225mm ID 47mm OD
• 10603295003595: SELF CENTERING BI-POLAR HEAD 22.225mm ID 46mm OD
• 10603295003588: SELF CENTERING BI-POLAR HEAD 22.225mm ID 45mm OD
• 10603295003571: SELF CENTERING BI-POLAR HEAD 22.225mm ID 44mm OD
• 10603295003564: SELF CENTERING BI-POLAR HEAD 22.225mm ID 43mm OD
• 10603295003557: SELF CENTERING BI-POLAR HEAD 22.225mm ID 42mm OD
• 10603295003540: SELF CENTERING BI-POLAR HEAD 22.225mm ID 41mm OD
• 10603295003533: SELF CENTERING BI-POLAR HEAD 22.225mm ID 40mm OD
• 10603295003526: SELF CENTERING BI-POLAR HEAD 22.225mm ID 39mm OD
• 10603295003519: SELF CENTERING BI-POLAR HEAD 28mm ID 65mm OD
• 10603295003502: SELF CENTERING BI-POLAR HEAD 28mm ID 63mm OD
• 10603295003496: SELF CENTERING BI-POLAR HEAD 28mm ID 61mm OD
• 10603295003489: SELF CENTERING BI-POLAR HEAD 28mm ID 59mm OD
• 10603295003472: SELF CENTERING BI-POLAR HEAD 28mm ID 57mm OD
• 10603295003465: SELF CENTERING BI-POLAR HEAD 28mm ID 56mm OD
• 10603295003458: SELF CENTERING BI-POLAR HEAD 28mm ID 55mm OD
• 10603295003441: SELF CENTERING BI-POLAR HEAD 28mm ID 54mm OD
• 10603295003434: SELF CENTERING BI-POLAR HEAD 28mm ID 53mm OD
• 10603295003427: SELF CENTERING BI-POLAR HEAD 28mm ID 52mm OD
• 10603295003410: SELF CENTERING BI-POLAR HEAD 28mm ID 51mm OD
• 10603295003403: SELF CENTERING BI-POLAR HEAD 28mm ID 50mm OD
• 10603295003397: SELF CENTERING BI-POLAR HEAD 28mm ID 49mm OD
• 10603295003380: SELF CENTERING BI-POLAR HEAD 28mm ID 48mm OD
• 10603295003373: SELF CENTERING BI-POLAR HEAD 28mm ID 47mm OD
• 10603295003366: SELF CENTERING BI-POLAR HEAD 28mm ID 46mm OD
• 10603295003359: SELF CENTERING BI-POLAR HEAD 28mm ID 45mm OD
• 10603295003342: SELF CENTERING BI-POLAR HEAD 28mm ID 44mm OD
• 10603295003335: SELF CENTERING BI-POLAR HEAD 28mm ID 43mm OD
• 10603295003328: SELF CENTERING BI-POLAR HEAD 28mm ID 42mm OD
• 10603295003311: SELF CENTERING BI-POLAR HEAD 28mm ID 41mm OD
• 10603295003304: SELF CENTERING BI-POLAR HEAD 28mm ID 40mm OD
• 10603295003298: SELF CENTERING BI-POLAR HEAD 28mm ID 39mm OD
• 10603295084419: SELF CENTERING MODULAR CATHCART HEMI HEAD INSTRUMENT TRAY