Tornier HRS ARS980922

GUDID 00846832093526

PTC Partially Coated Distal Stem

TORNIER, INC.

Coated shoulder humeral stem prosthesis

• Primary Device ID: 00846832093526
• NIH Device Record Key: ecac084d-29da-4c8e-82b6-279dfdd26dae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tornier HRS
• Version Model Number: ARS980922
• Catalog Number: ARS980922
• 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: 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: +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

• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 210 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832093526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191318

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: 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