546101000

GUDID 10603295174462

PREP KIT W/RESTRICTORS

DEPUY ORTHOPAEDICS, INC.

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 10603295174462
• NIH Device Record Key: af4a41d2-d5bd-48cf-89b9-1ee67f5d7b05
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5461-01-000
• Catalog Number: 546101000
• 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	10603295174462 [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: 4
• Public Version Date: 2024-02-05
• Device Publish Date: 2015-09-24

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

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• 10603295552420 - EMPHASYS: 2024-10-14 EMPHASYS MAKE TO ORDER CUP IMPACTOR TIP ADAPTOR
• 10603295011507 - PINNACLE: 2024-10-02 PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 28mm ID 48mm OD
• 10603295011514 - PINNACLE: 2024-10-02 PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 28mm ID 50mm OD
• 10603295011521 - PINNACLE: 2024-10-02 PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 10 DEGREE 28mm ID 48mm OD
• 10603295011538 - PINNACLE: 2024-10-02 PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 10 DEGREE 28mm ID 50mm OD
• 10603295011866 - PINNACLE: 2024-10-02 PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 32mm ID 52mm OD
• 10603295011873 - PINNACLE: 2024-10-02 PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 32mm ID 54mm OD