229990030

GUDID 10603295115298

CAS HIP NAVIGATED MI INSERTER

DEPUY ORTHOPAEDICS, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10603295115298
• NIH Device Record Key: f38f7866-0a3f-401f-88b3-a6cd61613a3b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2299-90-030
• Catalog Number: 229990030
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295115298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052178

FDA Product Code

• HAW: Neurological stereotaxic Instrument
• HXO: PUSHER, SOCKET

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10603295115298]

Moist Heat or Steam Sterilization

[10603295115298]

Moist Heat or Steam Sterilization

[10603295115298]

Moist Heat or Steam Sterilization

[10603295115298]

Moist Heat or Steam Sterilization

[10603295115298]

Moist Heat or Steam Sterilization

[10603295115298]

Moist Heat or Steam Sterilization

[10603295115298]

Moist Heat or Steam Sterilization

[10603295115298]

Moist Heat or Steam Sterilization

[10603295115298]

Moist Heat or Steam Sterilization

[10603295115298]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-06-30

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

• 10603295005063 - GLOBAL ADVANTAGE: 2025-03-06 GLOBAL ADVANTAGE HUMERAL HEAD SIZE 40mm x 15mm
• 10603295005070 - GLOBAL ADVANTAGE: 2025-03-06 GLOBAL ADVANTAGE HUMERAL HEAD SIZE 40mm x 18mm
• 10603295005087 - GLOBAL ADVANTAGE: 2025-03-06 GLOBAL ADVANTAGE HUMERAL HEAD SIZE 40mm x 21mm
• 10603295005094 - GLOBAL ADVANTAGE: 2025-03-06 GLOBAL ADVANTAGE HUMERAL HEAD SIZE 44mm x 15mm
• 10603295005100 - GLOBAL ADVANTAGE: 2025-03-06 GLOBAL ADVANTAGE HUMERAL HEAD SIZE 44mm x 18mm
• 10603295005117 - GLOBAL ADVANTAGE: 2025-03-06 GLOBAL ADVANTAGE HUMERAL HEAD SIZE 44mm x 21mm
• 10603295005124 - GLOBAL ADVANTAGE: 2025-03-06 GLOBAL ADVANTAGE ECCENTRIC HEAD SIZE 44mm x 18mm
• 10603295005131 - GLOBAL ADVANTAGE: 2025-03-06 GLOBAL ADVANTAGE ECCENTRIC HEAD SIZE 44mm x 21mm