DualX Inserter Handle

GUDID B70712535016A0

DualX Inserter Handle

AMPLIFY SURGICAL, INC.

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

• Primary Device ID: B70712535016A0
• NIH Device Record Key: 31699898-0bbb-49a3-9817-e971754f85f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DualX Inserter Handle
• Version Model Number: 12535016A0
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B70712535016A0 [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

[B70712535016A0]

Moist Heat or Steam Sterilization

[B70712535016A0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-13
• Device Publish Date: 2019-01-08

On-Brand Devices [DualX Inserter Handle]

• B70712535016A0: DualX Inserter Handle
• B707125350160: DualX Inserter Handle Rev C
• B707125350180: DualX Inserter Handle
• B707125350170: DualX Inserter Handle