CEMENTRALIZER 137646000

GUDID 10603295034544

CEMENTRALIZER STEM CENTRALIZER 8.5mm CEMENTED

DEPUY ORTHOPAEDICS, INC.

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

• Primary Device ID: 10603295034544
• NIH Device Record Key: 1bc4f2f7-123d-4499-a600-485c0f564530
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEMENTRALIZER
• Version Model Number: 1376-46-000
• Catalog Number: 137646000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• Device Count: 1
• DM Exempt: true
• 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
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• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295034544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K871510

FDA Product Code

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

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: 2020-09-17
• Device Publish Date: 2015-03-24

On-Brand Devices [CEMENTRALIZER]

• 10603295034568: CEMENTRALIZER STEM CENTRALIZER 10.0mm CEMENTED
• 10603295034551: CEMENTRALIZER STEM CENTRALIZER 9.25mm CEMENTED
• 10603295034544: CEMENTRALIZER STEM CENTRALIZER 8.5mm CEMENTED
• 10603295034537: CEMENTRALIZER STEM CENTRALIZER 10.5mm CEMENTED
• 10603295034520: CEMENTRALIZER STEM CENTRALIZER 15.0mm CEMENTED
• 10603295034513: CEMENTRALIZER STEM CENTRALIZER 14.0mm CEMENTED
• 10603295034506: CEMENTRALIZER STEM CENTRALIZER 19.0mm CEMENTED
• 10603295034490: CEMENTRALIZER STEM CENTRALIZER 18.0mm CEMENTED
• 10603295034483: CEMENTRALIZER STEM CENTRALIZER 17.0mm CEMENTED
• 10603295034476: CEMENTRALIZER STEM CENTRALIZER 16.0mm CEMENTED
• 10603295034469: CEMENTRALIZER STEM CENTRALIZER 13.0mm CEMENTED
• 10603295034452: CEMENTRALIZER STEM CENTRALIZER 12.0mm CEMENTED
• 10603295034445: CEMENTRALIZER STEM CENTRALIZER 11.0mm CEMENTED