PR701480

GUDID 00724995151850

The Laparoscopic Insulation Tester checks the integrity of the insulation on laparoscopic instruments. This unit is intended to verify insulation integrity on laparoscopic instruments.

Corporation Steris Canada

Multi-parameter device tester

• Primary Device ID: 00724995151850
• NIH Device Record Key: d10bdc38-7061-4c58-942a-16503a7675e6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PR701480
• Catalog Number: PR701480
• Company DUNS: 202659140
• Company Name: Corporation Steris Canada
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• 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: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995151850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120416

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-27
• Device Publish Date: 2016-09-13

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