DartFire Edge D2420011

GUDID 00889797099288

Screw

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00889797099288
• NIH Device Record Key: 292ba8a5-ff37-403f-a1fd-2090aa6cbd31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DartFire Edge
• Version Model Number: D2420011
• Catalog Number: D2420011
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797099288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053394

FDA Product Code

• HWC: Screw, fixation, bone

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: 2022-10-05
• Device Publish Date: 2022-09-27

On-Brand Devices [DartFire Edge]

• 00889797099332: Screw
• 00889797099325: Screw
• 00889797099318: Screw
• 00889797099301: Screw
• 00889797099295: Screw
• 00889797099288: Screw
• 00889797099431: Instrument Pack
• 00889797099424: Instrument Pack
• 00889797099417: Instrument Pack
• 00889797099400: Instrument Pack
• 00889797099387: Instrument Pack
• 00889797099370: Instrument Pack
• 00889797099363: Instrument Pack
• 00889797099356: Instrument Pack
• 00889797099349: Instrument Pack
• 00889797089852: Cannulated Screw
• 00889797089845: Cannulated Screw
• 00889797089838: Cannulated Screw
• 00889797089821: Cannulated Screw
• 00889797089814: Cannulated Screw
• 00889797089807: Cannulated Screw
• 00889797089791: Cannulated Screw
• 00889797089784: Cannulated Screw
• 00889797089777: Cannulated Screw
• 00889797089760: Cannulated Screw
• 00889797089753: Cannulated Screw
• 00889797089746: Cannulated Screw
• 00889797089739: Cannulated Screw
• 00889797089722: Cannulated Screw
• 00889797089715: Cannulated Screw
• 00889797089708: Cannulated Screw
• 00889797089692: Cannulated Screw
• 00889797089685: Cannulated Screw
• 00889797089678: Cannulated Screw
• 00889797088862: Cannulated Screw
• 00889797088855: Cannulated Screw
• 00889797088848: Cannulated Screw
• 00889797088831: Cannulated Screw
• 00889797088824: Cannulated Screw
• 00889797088817: Cannulated Screw
• 00889797088800: Cannulated Screw
• 00889797088794: Cannulated Screw
• 00889797088787: Cannulated Screw
• 00889797088770: Cannulated Screw
• 00889797088763: Cannulated Screw
• 00889797088756: Cannulated Screw
• 00889797088749: Cannulated Screw
• 00889797088732: Cannulated Screw
• 00889797088725: Cannulated Screw
• 00889797088718: Cannulated Screw