Multiple Procedure Torque-Limiting Handle 6219-00

GUDID 00811954013226

INTERVENTIONAL SPINE, INC

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00811954013226
• NIH Device Record Key: ebd64665-18b3-4747-b3b9-b61215890ecc
• Commercial Distribution Discontinuation: 2016-12-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Multiple Procedure Torque-Limiting Handle
• Version Model Number: 6219-00
• Catalog Number: 6219-00
• 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: true
• 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	00811954013226 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00811954013226]

Moist Heat or Steam Sterilization

[00811954013226]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-09
• Device Publish Date: 2016-03-16

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