Rasp 6191-00

GUDID 81195401179624

INTERVENTIONAL SPINE, INC

Bone file/rasp, manual Bone file/rasp, manual Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable

• Primary Device ID: 81195401179624
• NIH Device Record Key: b6590a80-b43c-46d4-a356-96ea714b317e
• Commercial Distribution Discontinuation: 2016-12-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Rasp
• Version Model Number: 6191-00
• Catalog Number: 6191-00
• 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: www.cs@i-spineinc.com
• Phone: 800-497-0484
• Email: www.cs@i-spineinc.com
• Phone: 800-497-0484
• Email: www.cs@i-spineinc.com
• Phone: 800-497-0484
• Email: www.cs@i-spineinc.com
• Phone: 800-497-0484
• Email: www.cs@i-spineinc.com
• Phone: 800-497-0484
• Email: www.cs@i-spineinc.com
• Phone: 800-497-0484
• Email: www.cs@i-spineinc.com
• Phone: 800-497-0484
• Email: www.cs@i-spineinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	81195401179624 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[81195401179624]

Moist Heat or Steam Sterilization

[81195401179624]

Moist Heat or Steam Sterilization

[81195401179624]

Moist Heat or Steam Sterilization

[81195401179624]

Moist Heat or Steam Sterilization

[81195401179624]

Moist Heat or Steam Sterilization

[81195401179624]

Moist Heat or Steam Sterilization

[81195401179624]

Moist Heat or Steam Sterilization

[81195401179624]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-12-07
• Device Publish Date: 2015-09-21

Devices Manufactured by INTERVENTIONAL SPINE, INC

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• 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