2.7mm Trephine Removal 6008

GUDID 00811954012694

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=523872#

INTERVENTIONAL SPINE, INC

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• Primary Device ID: 00811954012694
• NIH Device Record Key: e316bef6-f424-476b-bd1d-864fc5ba48d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.7mm Trephine Removal
• Version Model Number: 6008
• Catalog Number: 6008
• 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
• 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	00811954012694 [Primary]

FDA Product Code

• HWK: Trephine

Sterilization

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

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

[00811954012694]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-12-22

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