AEQUALIS™ PerFORM

GUDID 03700386937538

TORNIER

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 03700386937538
• NIH Device Record Key: 1a032609-d5b2-4bf3-86e9-835f313c1aea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEQUALIS™ PerFORM
• Version Model Number: DWE423
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	03700386937538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111902

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™ PerFORM]

• 03700386937682: DWE533
• 03700386937675: DWE532
• 03700386937668: DWE531
• 03700386937651: DWE523
• 03700386937644: DWE522
• 03700386937637: DWE521
• 03700386937620: DWE513
• 03700386937613: DWE512
• 03700386937606: DWE511
• 03700386937590: DWE503
• 03700386937583: DWE502
• 03700386937576: DWE501
• 03700386937569: DWE433
• 03700386937552: DWE432
• 03700386937545: DWE431
• 03700386937538: DWE423
• 03700386937521: DWE422
• 03700386937514: DWE421
• 03700386937507: DWE413
• 03700386937491: DWE412
• 03700386937484: DWE411
• 03700386937477: DWE403
• 03700386937460: DWE402
• 03700386937453: DWE401
• 03700386937446: DWE333
• 03700386937439: DWE332
• 03700386937422: DWE331
• 03700386937415: DWE323
• 03700386937408: DWE322
• 03700386937392: DWE321
• 03700386937385: DWE313
• 03700386937378: DWE312
• 03700386937361: DWE311
• 03700386937354: DWE303
• 03700386937347: DWE302
• 03700386937330: DWE301