546022000

GUDID 10603295174387

CEMENT RESTRICTOR SIZE 7 23.75mm

DEPUY ORTHOPAEDICS, INC.

Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable Polymer orthopaedic cement restrictor, non-bioabsorbable

• Primary Device ID: 10603295174387
• NIH Device Record Key: c42457d5-3190-446d-a7ef-d4edaa75683b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5460-22-000
• Catalog Number: 546022000
• 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
• 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	10603295174387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800894

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: 5
• Public Version Date: 2024-02-05
• Device Publish Date: 2015-09-24

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• 10603295551607 - ATTUNE: 2024-05-13 ATTUNE KNEE SYSTEM FLEXION SIZER-BALANCER TRAY
• 10603295548928 - EMPHASYS: 2024-05-08 EMPHASYS MAKE TO ORDER SHORTENED TIP
• 10603295123132 - MORELAND: 2024-04-03 MORELAND REV INST SCREW TREPHINE REAMER 6.5mm
• 10603295123293 - MORELAND: 2024-04-03 MORELAND REV INST TREPHINE REAMER 11mm 5.5 IN