Visualase
GUDID 00643169584440
SYSTEM 002-1100 15W THERMAL THERAPY
MEDTRONIC NAVIGATION, INC.
General/multiple surgical diode laser system| Primary Device ID | 00643169584440 |
| NIH Device Record Key | ce39be2e-544e-4469-9cef-71182f2b64c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Visualase |
| Version Model Number | 002-1100 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169584440 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081656
FDA Product Code
| GEX | Powered laser surgical instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-26 |
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 |
Trademark Results [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 |
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