LEGEND II 249046000

GUDID 10603295125884

LEGEND II PROXIMAL TIBIA RESECTION GDE

DEPUY ORTHOPAEDICS, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10603295125884
• NIH Device Record Key: 99d9253f-3561-4068-8a6c-c1c1ad1b8359
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEGEND II
• Version Model Number: 2490-46-000
• Catalog Number: 249046000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295125884 [Primary]

FDA Product Code

• HWT: TEMPLATE

Sterilization

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

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

[10603295125884]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2018-09-24

On-Brand Devices [LEGEND II]

• 10603295125914: LEGEND II SLAP HAMMER EXTRACTOR
• 10603295125952: LEGEND II FIXATION PIN .125in x 3in
• 10603295125853: LEGEND II .125DRILL W/DEPTH STOP
• 10603295125884: LEGEND II PROXIMAL TIBIA RESECTION GDE
• 10603295125877: LEGEND II IM ALIGNMENT ROD TIBIAL
• 10603295125860: LEGEND II FEMORAL TRIAL IMPACTOR