Aequalis Flex Revive ARS744105

GUDID 00846832094769

Screwless Trial Proximal Body

TORNIER, INC.

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• Primary Device ID: 00846832094769
• NIH Device Record Key: f6ac9b18-5617-4a28-a720-8356b5425d1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aequalis Flex Revive
• Version Model Number: ARS744105
• Catalog Number: ARS744105
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com

Device Dimensions

• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter
• Outer Diameter: 17 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832094769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181420

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

[00846832094769]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-23
• Device Publish Date: 2022-11-15

On-Brand Devices [Aequalis Flex Revive]

• 00846832094783: Trial Proximal Body Screw
• 00846832094776: Screwless Trial Proximal Body
• 00846832094769: Screwless Trial Proximal Body
• 00846832094752: Screwless Trial Proximal Body
• 00846832094745: Screwless Trial Proximal Body
• 00846832094738: Screwless Trial Proximal Body
• 00846832094721: Screwless Trial Proximal Body