Pre-Drill 6118

GUDID 81195401046100

INTERVENTIONAL SPINE, INC

Cannulated surgical drill bit, reusable

• Primary Device ID: 81195401046100
• NIH Device Record Key: 1754ba93-affe-4e12-980f-eff0e9a150a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pre-Drill
• Version Model Number: 6118
• Catalog Number: 6118
• 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	81195401046100 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[81195401046100]

Moist Heat or Steam Sterilization

[81195401046100]

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: 2015-09-21

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