ION Disposable XXXX

GUDID 00850040139693

SURGENTEC, LLC

Implantable cervical facet joint distractor

• Primary Device ID: 00850040139693
• NIH Device Record Key: 9d06692b-7402-41c5-baf1-55f84f87a1c4
• Commercial Distribution Discontinuation: 2024-09-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ION Disposable XXXX
• Version Model Number: SR19-2205
• Company DUNS: 004095409
• Company Name: SURGENTEC, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850040139693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240086

FDA Product Code

• MRW: System, Facet Screw Spinal Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-01
• Device Publish Date: 2024-09-23

On-Brand Devices [ION Disposable XXXX ]

• 00850040139709: SR19-2206
• 00850040139693: SR19-2205
• 00850040139655: SR19-2007