3.8 CS Flexible Cortex Drill Assembly 6100-00

GUDID 81195401072086

INTERVENTIONAL SPINE, INC

Cannulated surgical drill bit, reusable

• Primary Device ID: 81195401072086
• NIH Device Record Key: 011fb1b7-7b7f-437a-9b2f-a9e8b6bcd668
• Commercial Distribution Discontinuation: 2016-12-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 3.8 CS Flexible Cortex Drill Assembly
• Version Model Number: 6100-00
• Catalog Number: 6100-00
• Company DUNS: 017663522
• Company Name: INTERVENTIONAL SPINE, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 497-0484
• Email: cs@i-spineinc.com
• Phone: (800) 497-0484
• Email: cs@i-spineinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	81195401072086 [Primary]

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[81195401072086]

Moist Heat or Steam Sterilization

[81195401072086]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-22
• Device Publish Date: 2015-09-18

Devices Manufactured by INTERVENTIONAL SPINE, INC

• 00011954013448 - 8 Degree Lordotic, Opticage Expandable Interbody Implant: 2020-02-24 22mm Width x 45mm Length by 11mm-16mm Footprint Length
• 81195401082986 - Opticage Expandable Interbody Implant: 2020-02-24 9mm Width x 21mm Length by 9mm-14mm Expandable Height
• 81195401107962 - Opticage Expandable Interbody Implant: 2020-02-24 9mm Width x 26mm Length by 9mm-14mm Expandable Height
• 81195401108648 - Opticage Expandable Interbody Implant: 2020-02-24 9mm Width x 30mm Length by 9mm-14mm Expandable Height
• 81195401109393 - Opticage Expandable Interbody Implant: 2020-02-24 10mm Width x 21mm Length by 9mm-14mm Expandable Height
• 81195401110900 - Opticage Expandable Interbody Implant: 2020-02-24 10mm Width x 26mm Length by 9mm-14mm Expandable Height
• 81195401111686 - Opticage Expandable Interbody Implant: 2020-02-24 10mm Width x 30mm Length by 9mm-14mm Expandable Height
• 81195401112362 - Opticage Expandable Interbody Implant: 2020-02-24 11mm Width x 21mm Length by 9mm-14mm Expandable Height