Tornier Perform® Anatomic Glenoid DWE522

GUDID 03700434022025

TORNIER

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 03700434022025
• NIH Device Record Key: bb497d0f-fe16-4f1d-b734-9670a836fff3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tornier Perform® Anatomic Glenoid
• Version Model Number: DWE522
• Catalog Number: DWE522
• 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: 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
• 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

• Device Size Text, specify: 0
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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700434022025 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-01
• Device Publish Date: 2022-03-24

On-Brand Devices [Tornier Perform® Anatomic Glenoid]

• 03700434022575: DWE433
• 03700434022551: DWE523
• 03700434022537: DWE521
• 03700434022476: DWE511
• 03700434022407: DWE513
• 03700434022322: DWE322
• 03700434022308: DWE401
• 03700434022278: DWE312
• 03700434022117: DWE333
• 03700434022094: DWE412
• 03700434022025: DWE522
• 03700434022001: DWE302
• 03700434021967: DWE512
• 03700434021929: DWE323
• 03700434021844: DWE422
• 03700434021837: DWE313
• 03700434021721: DWE413
• 03700434021714: DWE421
• 03700434021615: DWE501
• 03700434021585: DWE411
• 03700434021530: DWE301
• 03700434021448: DWE423
• 03700434021370: DWE502
• 03700434021165: DWE402
• 03700434021127: DWE332
• 03700434021042: DWE431
• 03700434020908: DWE531
• 03700434020847: DWE533
• 03700434020786: DWE331
• 03700434019780: DWE321
• 03700434019742: DWE311
• 03700434019667: DWE403
• 03700434019445: DWE432
• 03700434019308: DWE303
• 03700434019186: DWE503
• 03700434019162: DWE532