Tornier HRS ARS980915

GUDID 00846832092963

PTC Partially Coated Distal Stem

TORNIER, INC.

Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis

• Primary Device ID: 00846832092963
• NIH Device Record Key: 21413871-3028-4f77-9be4-0dbd426ba1b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tornier HRS
• Version Model Number: ARS980915
• Catalog Number: ARS980915
• 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
• 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

• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 170 Millimeter
• Outer Diameter: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832092963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191318

FDA Product Code

• PHX: shoulder prosthesis, reverse configuration

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: 2023-08-10
• Device Publish Date: 2023-08-02

On-Brand Devices [Tornier HRS]

• 00840338602756: Sounder
• 00840338602749: Sounder
• 00840338602732: Sounder
• 00840338602725: Sounder
• 00840338602718: Sounder
• 00840338602701: Sounder
• 00846832093502: PTC Partially Coated Distal Stem
• 00846832093298: Assembly Screw
• 00846832093274: Assembly Screw
• 00846832093250: Assembly Screw
• 00846832093212: PTC Distal Stem
• 00846832093205: PTC Distal Stem
• 00846832093182: PTC Distal Stem
• 00846832093175: PTC Distal Stem
• 00846832093151: PTC Distal Stem
• 00846832093144: PTC Distal Stem
• 00846832093113: PTC Distal Stem
• 00846832093083: PTC Distal Stem
• 00846832093069: PTC Distal Stem
• 00846832093052: PTC Distal Stem
• 00846832093045: PTC Distal Stem
• 00846832093038: PTC Distal Stem
• 00846832093014: PTC Distal Stem
• 00846832092956: PTC Partially Coated Distal Stem
• 00846832092925: PTC Partially Coated Distal Stem
• 00846832092918: PTC Partially Coated Distal Stem
• 00846832092901: PTC Partially Coated Distal Stem
• 00846832092895: PTC Partially Coated Distal Stem
• 00846832092888: PTC Partially Coated Distal Stem
• 00846832092871: PTC Partially Coated Distal Stem
• 00846832092857: PTC Partially Coated Distal Stem
• 00846832092840: PTC Partially Coated Distal Stem
• 00846832092833: PTC Partially Coated Distal Stem
• 00846832092826: PTC Partially Coated Distal Stem
• 00846832092765: PTC Proximal Body
• 00846832092758: PTC Proximal Body
• 00846832092741: PTC Proximal Body
• 00846832092734: PTC Proximal Body
• 00846832092727: PTC Proximal Body
• 00846832092680: Spacer
• 00846832092673: Spacer
• 00846832092666: Spacer
• 00846832092628: Spacer
• 00846832092611: Spacer
• 00846832092604: Spacer
• 00846832092598: Spacer
• 00846832093557: PTC Partially Coated Distal Stem
• 00846832093540: PTC Partially Coated Distal Stem
• 00846832093526: PTC Partially Coated Distal Stem
• 00846832093236: PTC Distal Stem