Tornier Flex Shoulder System DWH054

GUDID 03700434020823

Tornier Pyrocarbon Humeral Head

TORNIER

Stem-fixed metallic humeral head prosthesis

• Primary Device ID: 03700434020823
• NIH Device Record Key: 32da97b6-6956-4004-a597-4ef8aa35dd8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tornier Flex Shoulder System
• Version Model Number: DWH054
• Catalog Number: DWH054
• 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: 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: +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
• 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

• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Height: 23 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700434020823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220012

FDA Product Code

• QKW: Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-03-06
• Device Publish Date: 2023-01-10

On-Brand Devices [Tornier Flex Shoulder System]

• 03700434022766: DWF343
• 03700434022759: DWF607A
• 03700434022742: DWF348
• 03700434022735: DWF501
• 03700434022728: DWF154
• 03700434022704: DWF143
• 03700434022698: DWF608C
• 03700434022681: DWF702C
• 03700434022667: DWF605A
• 03700434022650: DWF252
• 03700434022636: DWF601B
• 03700434022629: DWF704B
• 03700434022605: DWF608B
• 03700434022599: DWF603A
• 03700434022568: DWF618C
• 03700434022520: DWF046
• 03700434022513: DWF353
• 03700434022490: DWF617C
• 03700434022469: DWF141
• 03700434022452: DWF246
• 03700434022391: DWF712B
• 03700434022377: DWF601C
• 03700434022346: DWF604A
• 03700434022339: DWF704C
• 03700434022315: DWF146
• 03700434022285: DWF512
• 03700434022261: DWF054
• 03700434022254: DWF718C
• 03700434022247: DWF250
• 03700434022216: DWF611C
• 03700434022193: DWF611B
• 03700434022186: DWF718B
• 03700434022179: DWF706C
• 03700434022155: DWF500
• 03700434022148: DWF510
• 03700434022131: DWF706B
• 03700434022124: DWF712C
• 03700434022087: DWF041
• 03700434022070: DWF355
• 03700434022063: DWF716B
• 03700434022056: DWF241
• 03700434022049: DWF716C
• 03700434022018: DWF354
• 03700434021974: DWF043
• 03700434021943: DWF237
• 03700434021936: DWF618A
• 03700434021905: DWF607C
• 03700434021899: DWF702A
• 03700434021882: DWF613A
• 03700434021875: DWF608A