T-Handle, Non-Ratcheting 6197-00

GUDID 81195401231162

PerX360 System, Non-Ratcheting T-Handle

INTERVENTIONAL SPINE, INC

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 81195401231162
• NIH Device Record Key: fbd69fb8-ac05-4d83-937f-48d43c12cc6f
• Commercial Distribution Discontinuation: 2016-12-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: T-Handle, Non-Ratcheting
• Version Model Number: 6197-00
• Catalog Number: 6197-00
• 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	81195401231162 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[81195401231162]

Moist Heat or Steam Sterilization

[81195401231162]

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: 2015-09-21

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