DUALX SCREW DRIVER

GUDID B707125340930

Dual X Screw Driver

AMPLIFY SURGICAL, INC.

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: B707125340930
• NIH Device Record Key: 314fb9a0-a585-4275-9ffe-9275a6c9a4cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX SCREW DRIVER
• Version Model Number: 12534093
• 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	B707125340930 [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

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

[B707125340930]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-18
• Device Publish Date: 2019-05-08

On-Brand Devices [DUALX SCREW DRIVER]

• B70712534093A0: Shaft for DualX screw driver
• B707125340930: Dual X Screw Driver