DUALX TORQUE LIMITING HANDLE

GUDID B70712534095A0

DUALX TORQUE LIMITING HANDLE

AMPLIFY SURGICAL, INC.

Surgical screwdriver, reusable

• Primary Device ID: B70712534095A0
• NIH Device Record Key: 016e4d71-ee6b-4426-a5f5-e5e61140b535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX TORQUE LIMITING HANDLE
• Version Model Number: 12534095A0
• 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: 949-220-1286
• Email: admin@innovasiveinc.com
• Phone: 949-220-1286
• Email: admin@innovasiveinc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B70712534095A0 [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

[B70712534095A0]

Moist Heat or Steam Sterilization

[B70712534095A0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-13
• Device Publish Date: 2019-01-08

Devices Manufactured by AMPLIFY SURGICAL, INC.

• B707125355860 - DUALX DUAL PORT HEMOSTATIC AGENT DELIVERY TUBE (USA): 2025-06-06 HEMOSTATIC AGENT DELIVERY TUBE US MANUFACTURE
• B70712535588001US0 - DUALX DUAL PORT CANNULA 30MM: 2025-06-06 30MM US MANUFACTURE
• B70712535588002US0 - DUALX DUAL PORT CANNULA 40MM: 2025-06-06 40MM US MANUFACTURE
• B70712535588003US0 - DUALX DUAL PORT CANNULA 50MM: 2025-06-06 50MM US MANUFACTURE
• B70712535588004US0 - DUALX DUAL PORT CANNULA 60MM: 2025-06-06 60MM US MANUFACTURE
• B70712535588005US0 - DUALX DUAL PORT CANNULA 70MM: 2025-06-06 70MM US MANUFACTURE
• B70712535588006US0 - DUALX DUAL PORTAL CANNULA 80MM: 2025-06-06 80MM US MANUFACTURE
• B70712535588007US0 - DUALX DUAL PORTAL CANNULA 90MM: 2025-06-06 90MM US MANUFACTURE