Simpliciti™

GUDID 00846832061297

TORNIER, INC.

Stem-fixed humeral head prosthesis

• Primary Device ID: 00846832061297
• NIH Device Record Key: 0f42bc25-76c6-4a13-a024-db25a85c8276
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpliciti™
• Version Model Number: 7122879
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 40 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832061297 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-16

On-Brand Devices [Simpliciti™]

• 00846832061440: DWG403
• 00846832061433: DWG402
• 00846832061426: DWG401
• 00846832061419: 7122891
• 00846832061402: 7122890
• 00846832061396: 7122889
• 00846832061389: 7122888
• 00846832061372: 7122887
• 00846832061365: 7122886
• 00846832061358: 7122885
• 00846832061341: 7122884
• 00846832061334: 7122883
• 00846832061327: 7122882
• 00846832061310: 7122881
• 00846832061303: 7122880
• 00846832061297: 7122879
• 00846832061280: 7122878
• 00846832061273: 7122877
• 00846832004904: 7122876
• 00846832004898: 7122875
• 00846832004881: 7122874
• 00846832004874: 7122873
• 00846832004867: 7122872
• 00846832004850: 7122871
• 00846832004843: 7122870
• 00846832004836: 7122869
• 00846832004829: 7122868