VISUALASE

GUDID 00763000521370

SYSTEM 9735542 15W VISUALASE

MEDTRONIC NAVIGATION, INC.

General/multiple surgical diode laser system

• Primary Device ID: 00763000521370
• NIH Device Record Key: b4224e82-43c2-47ad-a29e-6ac1ba47d74d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISUALASE
• Version Model Number: 9735542
• Company DUNS: 835233107
• Company Name: MEDTRONIC NAVIGATION, INC.
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000521370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211269

FDA Product Code

• ONO: Neurosurgical laser with MR thermography

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-12
• Device Publish Date: 2024-08-03

On-Brand Devices [VISUALASE]

• 00643169969421: TUBE SET 9735998 CRANIAL REDUCING
• 00643169933415: ACCESSORY KIT 9735571 VISUALASE NEURO
• 00643169933408: ACCESSORY KIT 9735570 VISUALASE BODY
• 00643169933385: VCLAS 9735560 10MM TIP/1.65MM CATHETER
• 00643169933378: VCLAS 9735561 15MM TIP/1.85MM CATHETER
• 00643169933361: VCLAS 9735559 3MM TIP/1.65MM CATHETER
• 00643169878181: COMPUTER 9735940 Z440 W/VISUALASE 3.2.1
• 00643169792890: SYSTEM 9735542 15W VISUALASE
• 00643169655935: SYSTEM 9735542 15W VISUALASE
• 00643169612037: VCLAS ACC KIT 9735571 NEURO
• 00643169612020: VCLAS ACC KIT 9735570 URO
• 00643169612006: VCLAS 9735561 .6MM CORE FIBER 15MM TIPA^
• 00643169611993: VCLAS 9735560 .4MM CORE FIBER 10MM TIP
• 00643169611986: VCLAS 9735559 .4MM CORE FIBER 3MM TIP
• 00643169590076: LASER 9735552 15W 980NM - VISUALASE
• 00643169584440: SYSTEM 002-1100 15W THERMAL THERAPY
• 00643169584419: VCLAS 001-6000 .6MM CORE FIBER 15MM TIP
• 00643169584402: VCLAS 001-4003 .4MM CORE FIBER 3MM TIP
• 00643169584396: VCLAS 001-4000 .4MM CORE FIBER 10MM TIP
• 00763000015695: VCLAS 9735561 15MM TIP 1.85MM CATHETER
• 00763000218171: VCLAS 9735559 3MM TIP/1.65MM CATHETER
• 00763000218195: VCLAS 9735561 15MM TIP/1.85MM CATHETER
• 00643169933392: STYLET 9735566 1MM VISUALIZATION
• 00763000218188: VCLAS 9735560 10MM TIP/1.65MM CATHETER
• 00643169590113: IV POLE 9735556 VISUALASE
• 00763000357504: SFW KIT 9736317 VISUALASE V1 US
• 00763000313364: SYSTEM 9735542 15W VISUALASE
• 00763000416461: ACCESSORY KIT 9735571 VISUALASE NEURO
• 00763000255954: ACCESSORY KIT 9735571 VISUALASE NEURO
• 00763000402099: SFW KIT 9736317 VISUALASE V1 US
• 00763000416454: STYLET 9735566 1MM VISUALIZATION
• 00643169612013: STYLET 9735566 VISUALIZATION 1MM
• 00763000402082: SYSTEM 9735542 15W VISUALASE
• 00763000416447: VCLAS 9735561 15MM TIP/1.85MM CATHETER
• 00763000416430: VCLAS 9735560 10MM TIP/1.65MM CATHETER
• 00763000416423: VCLAS 9735559 3MM TIP/1.65MM CATHETER
• 00763000521462: SFW UPGRADE KIT 9736317 VISUALASE-USA
• 00763000620851: ACCESSORY KIT 9735571 VISUALASE NEURO
• 00763000620844: STYLET 9735566 1MM VISUALIZATION
• 00763000521370: SYSTEM 9735542 15W VISUALASE