DUALX DUAL PORTAL SUCTION TUBE W/ STYLET

GUDID B7071011140

SUCTION TUBE W/ STYLET

Amplify Surgical, Inc.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: B7071011140
• NIH Device Record Key: 3137daa5-9a3d-4c4c-8948-4d8ee88c02cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX DUAL PORTAL SUCTION TUBE W/ STYLET
• Version Model Number: 101114
• Company DUNS: 081021000
• Company Name: Amplify Surgical, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B7071011140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181397

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

[B7071011140]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-18
• Device Publish Date: 2023-08-10

Devices Manufactured by Amplify Surgical, Inc.

• B707125355740300 - DUALX DUAL PORTAL DISPOSABLE KIT-30MM (USA): 2026-03-13 INCLUDES: CANNULA 30MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355740400 - DUALX DUAL PORTAL DISPOSABLE KIT-40MM (USA): 2026-03-13 INCLUDES: CANNULA 40MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355740500 - DUALX DUAL PORTAL DISPOSABLE KIT-50MM (USA): 2026-03-13 INCLUDES: CANNULA 50MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355740600 - DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA): 2026-03-13 INCLUDES: CANNULA 60MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355740700 - DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA): 2026-03-13 INCLUDES: CANNULA 70MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355740800 - DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA): 2026-03-13 INCLUDES: CANNULA 80MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355740900 - DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA): 2026-03-13 INCLUDES: CANNULA 90MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355741000 - DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA): 2026-03-13 INCLUDES: CANNULA 100MM HEMOSTATIC AGENT DELIVERY TUBE