VersaCut Blade Set

GUDID 07290109140605

Additional DM DI:07290109143767

LUMENIS LTD.

Tissue morcellation system

• Primary Device ID: 07290109140605
• NIH Device Record Key: 5778c7fb-ebc7-40dc-8516-3dc85400f3e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCut Blade Set
• Version Model Number: VersaCut Blade Set
• 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: 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: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109140605 [Primary]
GS1	07290109143750 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050639

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

[07290109140605]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-29
• Device Publish Date: 2016-08-23

Devices Manufactured by LUMENIS LTD.

• 07290109147161 - Lumenis Pulse 120H: 2025-02-26
• 07290109147178 - Lumenis Pulse 120H: 2025-02-26
• 07290109147185 - Lumenis Pulse, Moses 2.0 (DOM): 2025-02-26
• 07290109147192 - Lumenis Pulse 120H: 2025-02-26
• 07290109147208 - Lumenis Pulse, Moses 2.0 (INT): 2025-02-26
• 07290109147215 - Lumenis Pulse 120H: 2025-02-26
• 07290109147222 - Lumenis Pulse 120H: 2025-02-26
• 07290109147291 - Lumenis Pulse 120H: 2025-02-26