FLEX SHOULDER SYSTEM

GUDID 03700386942723

TORNIER

Stem-fixed metallic humeral head prosthesis

• Primary Device ID: 03700386942723
• NIH Device Record Key: 4d787a99-e0fc-4dbc-a5f9-bad09eb25b0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEX SHOULDER SYSTEM
• Version Model Number: DWG141
• Company DUNS: 260324876
• Company Name: TORNIER
• 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: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com

Device Dimensions

• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter
• Height: 15 Millimeter
• Outer Diameter: 39 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700386942723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122698

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-03-06
• Device Publish Date: 2015-10-16

On-Brand Devices [FLEX SHOULDER SYSTEM]

• 03700386958014: REAMER TIP
• 03700386958007: MANUAL PLANER REAMER
• 03700386957994: MANUAL PLANER REAMER
• 03700386957987: MANUAL PLANER REAMER
• 03700386942884: DWG157
• 03700386942877: DWG156
• 03700386942860: DWG155
• 03700386942853: DWG154
• 03700386942846: DWG153
• 03700386942839: DWG152
• 03700386942822: DWG151
• 03700386942815: DWG150
• 03700386942808: DWG149
• 03700386942792: DWG148
• 03700386942785: DWG147
• 03700386942778: DWG146
• 03700386942761: DWG145
• 03700386942754: DWG144
• 03700386942747: DWG143
• 03700386942730: DWG142
• 03700386942723: DWG141
• 03700386942709: DWG139
• 03700386942693: DWG057
• 03700386942686: DWG056
• 03700386942679: DWG055
• 03700386942662: DWG054
• 03700386942655: DWG053
• 03700386942648: DWG052
• 03700386942631: DWG051
• 03700386942624: DWG050
• 03700386942617: DWG049
• 03700386942600: DWG048
• 03700386942594: DWG047
• 03700386942587: DWG046
• 03700386942570: DWG045
• 03700386942563: DWG044
• 03700386942556: DWG043
• 03700386942549: DWG042
• 03700386942532: DWG041
• 03700386942518: DWG039
• 03700386940484: DWF355
• 03700386940477: DWF354
• 03700386940460: DWF353
• 03700386940453: DWF352
• 03700386940446: DWF351
• 03700386940439: DWF350
• 03700386940422: DWF348
• 03700386940415: DWF346
• 03700386940408: DWF343
• 03700386940392: DWF341