AEQUALIS REVERSED II

GUDID 03700386935930

TORNIER

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 03700386935930
• NIH Device Record Key: 8dcfd182-4ab9-4aca-9caa-be18bba78295
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEQUALIS REVERSED II
• Version Model Number: DWD195
• 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
• 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: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700386935930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081059

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 REVERSED II]

• 03700386952890: DWE892
• 03700386952883: DWE891
• 03700386952876: DWE890
• 03700386952869: DWE882
• 03700386952852: DWE881
• 03700386952845: DWE880
• 03700386952838: DWE872
• 03700386952821: DWE871
• 03700386952814: DWE870
• 03700386952807: DWE862
• 03700386952791: DWE861
• 03700386952784: DWE860
• 03700386935930: DWD195
• 03700386935923: DWD194
• 03700386935916: DWD193
• 03700386935909: DWD192
• 03700386935893: DWD191
• 03700386935886: DWD190
• 03700386935879: DWD185
• 03700386935862: DWD184
• 03700386935855: DWD183
• 03700386935848: DWD182
• 03700386935831: DWD181
• 03700386935824: DWD180
• 03700386952753: DWE840
• 03700386952746: DWE835
• 03700386952722: DWE825
• 03700386952715: DWE820
• 03700386952678: DWE735
• 03700386952647: DWE720
• 03700386955273: DWH919
• 03700386955266: DWH918
• 03700386955259: DWH917
• 03700386955242: DWH916
• 03700386955235: DWH915
• 03700386955228: DWH914
• 03700386955211: DWH913
• 03700386955204: DWH912
• 03700386955198: DWH911
• 03700386955174: DWH909
• 03700386955150: DWH908
• 03700386955136: DWH907
• 03700386955112: DWH906
• 03700386955099: DWH905
• 03700386955075: DWH904
• 03700386955051: DWH903
• 03700386955037: DWH902
• 03700386955013: DWH901
• 03700386952777: DWE850
• 03700386952760: DWE845