Tornier Simpliciti® Shoulder System 7122889

GUDID 00846832091683

TORNIER, INC.

Stem-fixed humeral head prosthesis

• Primary Device ID: 00846832091683
• NIH Device Record Key: a037d9f4-6c87-4c60-8230-96b3a59c2b13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tornier Simpliciti® Shoulder System
• Version Model Number: 7122889
• Catalog Number: 7122889
• 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

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 56 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832091683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143552

FDA Product Code

• PKC: Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

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: 2022-05-03
• Device Publish Date: 2022-04-25

On-Brand Devices [Tornier Simpliciti® Shoulder System]

• 00846832091874: DWG401
• 00846832092055: 7122877
• 00846832092017: 7122884
• 00846832091942: 7122882
• 00846832091904: 7122887
• 00846832091898: 7122880
• 00846832091881: 7122886
• 00846832091843: 7122878
• 00846832091744: 7122881
• 00846832091706: 7122883
• 00846832091683: 7122889
• 00846832091652: 7122891
• 00846832091577: 7122885
• 00846832091546: 7122890
• 00846832091508: 7122879
• 00846832091485: 7122888
• 00846832090549: 7122869
• 00846832090532: 7122868
• 00846832090495: 7122876
• 00846832090488: 7122875
• 00846832090471: 7122874
• 00846832090464: 7122873
• 00846832090457: 7122872
• 00846832090440: 7122871
• 00846832090433: 7122870