EXRAY30 HVP3021

GUDID 03701091001392

Self-compressive cannulated screw

ADSM

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 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: 03701091001392
• NIH Device Record Key: c776b518-f159-4ee9-ae29-6e3d8c7d435f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXRAY30
• Version Model Number: HVP3021
• Catalog Number: HVP3021
• Company DUNS: 266749350
• Company Name: ADSM
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com

Device Dimensions

• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 21 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701091001392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151241

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: 2020-12-24
• Device Publish Date: 2020-12-16

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• 03701091001415: Self-compressive cannulated screw
• 03701091001408: Self-compressive cannulated screw
• 03701091001392: Self-compressive cannulated screw
• 03701091001385: Self-compressive cannulated screw
• 03701091001378: Self-compressive cannulated screw
• 03701091001361: Self-compressive cannulated screw
• 03701091001354: Self-compressive cannulated screw
• 03701091001347: Self-compressive cannulated screw