299961784

GUDID 10603295164661

MAKE TO ORDER GLENOSPHERE ORIENTATION GUIDE LONG

DEPUY ORTHOPAEDICS, INC.

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10603295164661
• NIH Device Record Key: cd28bf42-2d25-40f1-9275-f7f51019a21a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2999-61-784
• Catalog Number: 299961784
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295164661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170748

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

[10603295164661]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-26
• Device Publish Date: 2021-07-16

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

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• 10603295551560 - ATTUNE: 2024-05-13 ATTUNE KNEE SYSTEM FLEXION SIZER-BALANCER ASSEMBLY
• 10603295551577 - ATTUNE: 2024-05-13 ATTUNE KNEE SYSTEM FLEXION SIZER-BALANCER STYLUS
• 10603295551584 - ATTUNE: 2024-05-13 ATTUNE KNEE SYSTEM FLEXION SIZER-BALANCER CR FOOT
• 10603295551591 - ATTUNE: 2024-05-13 ATTUNE KNEE SYSTEM FLEXION SIZER-BALANCER PS FOOT
• 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