DUALX SCREW THREAD CLEARING TOOL

GUDID B707125342080

DUALX SCREW THREAD CLEARING TOOL THIS DEVICE IS EXACTLY THE SAME AS PRIMARY DI NUMBER: B707125352080

AMPLIFY SURGICAL, INC.

Surgical screwdriver, reusable

• Primary Device ID: B707125342080
• NIH Device Record Key: c507d159-471a-4a33-96aa-4fbdec04e448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX SCREW THREAD CLEARING TOOL
• Version Model Number: 12534208
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707125342080 [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

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

[B707125342080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-17
• Device Publish Date: 2019-07-23

On-Brand Devices [DUALX SCREW THREAD CLEARING TOOL]

• B707125352080: DUALX SCREW THREAD CLEARING TOOL THIS DEVICE IS EXACTLY THE SAME AS PRIMARY DI NUMBER: B7071253
• B707125342080: DUALX SCREW THREAD CLEARING TOOL THIS DEVICE IS EXACTLY THE SAME AS PRIMARY DI NUMBER: B7071253