Dual X Fixed Handle

GUDID B707125341110

Dual X Fixed Handle

Amplify Surgical, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: B707125341110
• NIH Device Record Key: eaa98915-6568-4dad-b5c0-f602ad1eff34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual X Fixed Handle
• Version Model Number: 12534111
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707125341110 [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

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

[B707125341110]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-05-21
• Device Publish Date: 2020-11-09

Devices Manufactured by Amplify Surgical, Inc.

• B707125355750 - DUALX DUAL PORT HEMOSTATIC AGENT DELIVERY TUBE (USA): 2024-04-03 HEMOSTATIC AGENT DELIVERY TUBE
• B707125355830010 - DUALX DUAL PORT CANNULA 30MM (USA): 2024-04-03 30MM
• B707125355830020 - DUALX DUAL PORT CANNULA 40MM (USA): 2024-04-03 40MM
• B707125355830030 - DUALX DUAL PORT CANNULA 50MM (USA): 2024-04-03 50MM
• B707125355830040 - DUALX DUAL PORT CANNULA 60MM (USA): 2024-04-03 60MM
• B707125355830050 - DUALX DUAL PORT CANNULA 70MM (USA): 2024-04-03 70MM
• B707125355830060 - DUALX DUAL PORTAL CANNULA 80MM (USA): 2024-04-03 80MM
• B707125355830070 - DUALX DUAL PORTAL CANNULA 90MM (USA): 2024-04-03 90MM