iO-Flex

GUDID 00840916103811

iO-Flex® Distal Handle

SPINAL ELEMENTS

Nerve-locating probe, single-use Nerve-locating probe, single-use Nerve-locating probe, single-use Nerve-locating probe, single-use Nerve-locating probe, single-use Nerve-locating probe, single-use Nerve-locating probe, single-use Nerve-locating probe, single-use Nerve-locating probe, single-use Nerve-locating probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use

• Primary Device ID: 00840916103811
• NIH Device Record Key: 34461a4d-de3d-44f9-9f01-531db146b7c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iO-Flex
• Version Model Number: iO-DH
• Company DUNS: 004022104
• Company Name: SPINAL ELEMENTS
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840916103811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113533

FDA Product Code

• HAE: Rongeur, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-12

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• 00840916103897: iO-Flex® Contra Irrigation Cannula
• 00840916103880: iO-Flex® Ipsi Irrigation Cannula
• 00840916103873: iO-Flex® Microblade Shaver® iO-Tome® Device 10mm
• 00840916103866: iO-Flex® Microblade Shaver® iO-Tome® Device 7.5mm
• 00840916103859: iO-Flex® MicroBlade Shaver® 12mm w/ side cutter
• 00840916103842: iO-Flex® MicroBlade Shaver® 10mm w/ side cutter
• 00840916103835: iO-Flex® MicroBlade Shaver® 7.5mm w/ side cutter
• 00840916103828: iO-Flex® MicroBlade Shaver® 5.5mm
• 00840916103811: iO-Flex® Distal Handle
• 00840916103804: iO-Flex® Neuro Check® w/ Wire
• 00840916103798: iO-Flex® Ipsi Probe TR
• 00840916103781: iO-Flex® Ipsi Probe S
• 00840916103774: iO-Flex® Contra Probe 45
• 00840916103767: iO-Flex® Wire