AEQUALIS GLENOID

GUDID 03700386915109

TORNIER

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 03700386915109
• NIH Device Record Key: 2feaeca0-a52d-4a52-980b-e4af6e97e56d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEQUALIS GLENOID
• Version Model Number: DWB006
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700386915109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060209

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: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2015-10-16

On-Brand Devices [AEQUALIS GLENOID]

• 03700386915482: DWB218
• 03700386915475: DWB217
• 03700386915468: DWB216
• 03700386915451: DWB215
• 03700386915444: DWB213
• 03700386915437: DWB212
• 03700386915420: DWB211
• 03700386915413: DWB210
• 03700386915123: DWB008
• 03700386915116: DWB007
• 03700386915109: DWB006
• 03700386915093: DWB005
• 03700386915086: DWB003
• 03700386915079: DWB002
• 03700386915062: DWB001