VersaCut+ Sterile Outer Blade

GUDID 07290109143156

LUMENIS LTD.

Tissue morcellation system

• Primary Device ID: 07290109143156
• NIH Device Record Key: 49c474e5-e550-40f7-8deb-2015f4fa4768
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCut+ Sterile Outer Blade
• Version Model Number: VersaCut+ Sterile Outer Blade
• Company DUNS: 600166524
• Company Name: LUMENIS LTD.
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 408-764-3000
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109143156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133272

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-25

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