TORNIER PERFORM™ Patient-Matched MWJ008

GUDID 03700434015898

TORNIER

Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 03700434015898
• NIH Device Record Key: 3a92b5a8-7154-481a-8f1e-f25395d241af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TORNIER PERFORM™ Patient-Matched
• Version Model Number: MWJ008
• Catalog Number: MWJ008
• Company DUNS: 260324876
• Company Name: TORNIER
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com

Device Dimensions

• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700434015898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211359

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, 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: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2022-01-05

On-Brand Devices [TORNIER PERFORM™ Patient-Matched]

• 03700434015904: MWJ015
• 03700434015898: MWJ008
• 03700434015881: MWJ007
• 03700434015874: MWJ006
• 03700434015867: MWJ005