546112000

GUDID 10603295174493

CEMENT RESTRICTOR LARGE

DEPUY ORTHOPAEDICS, INC.

Polymer orthopaedic cement restrictor, non-bioabsorbable

• Primary Device ID: 10603295174493
• NIH Device Record Key: 13710ba8-657a-41f7-8c9f-e8764eb39683
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5461-12-000
• Catalog Number: 546112000
• 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
• 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	10603295174493 [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

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

• 10603295086918 - NA: 2024-11-07 REAMER HOLE GAUGE
• 10603295216742 - P.F.C.: 2024-11-07 P.F.C. UNIVERSAL MODULAR STEM WRENCH
• 10603295227304 - SIGMA LCS HIGH PERFORMANCE: 2024-11-07 SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH CEMENTED SIZE 1-1.5
• 10603295227311 - SIGMA LCS HIGH PERFORMANCE: 2024-11-07 SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH CEMENTED SIZE 2-3
• 10603295227328 - SIGMA LCS HIGH PERFORMANCE: 2024-11-07 SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH CEMENTED SIZE 4-7
• 10603295227335 - SIGMA LCS HIGH PERFORMANCE: 2024-11-07 SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED SIZE 1-1.5
• 10603295227342 - SIGMA LCS HIGH PERFORMANCE: 2024-11-07 SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED SIZE 2-3
• 10603295227359 - SIGMA LCS HIGH PERFORMANCE: 2024-11-07 SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED SIZE 4-7