| Primary Device ID | 00763000416454 | 
| NIH Device Record Key | 216e875b-2ba1-4caa-b682-41737ddc5c03 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Visualase | 
| Version Model Number | 9735566 | 
| Company DUNS | 835233107 | 
| Company Name | MEDTRONIC NAVIGATION, 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 | true | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00763000416454 [Primary] | 
| GAH | STYLET, SURGICAL, GENERAL & PLASTIC SURGERY | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-03-01 | 
| Device Publish Date | 2021-02-21 | 
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  VISUALASE  88714864  not registered Live/Pending | Visualase, Inc. 2019-12-04 | 
|  VISUALASE  85298274  4056436 Live/Registered | Visualase, Inc. 2011-04-19 | 
|  VISUALASE  78101715  2704702 Dead/Cancelled | VISUALASE, INC. 2002-01-09 |