AEQUALIS™ PerFORM+ Reversed

GUDID 00846832062034

TORNIER, INC.

Reverse shoulder prosthesis base plate

• Primary Device ID: 00846832062034
• NIH Device Record Key: 02fd06cc-ca3b-4679-9de4-1522f4c09b8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEQUALIS™ PerFORM+ Reversed
• Version Model Number: DWJ514
• Company DUNS: 968990812
• Company Name: TORNIER, INC.
• 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: +1(888)494-7950
• Email: customerservice@tornier.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832062034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161742

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-21

On-Brand Devices [AEQUALIS™ PerFORM+ Reversed]

• 00846832062065: DWJ505
• 00846832062058: DWJ515
• 00846832062041: DWJ504
• 00846832062034: DWJ514
• 00846832062027: DWJ503
• 00846832062010: DWJ502
• 00846832062003: DWJ513
• 00846832061990: DWJ512