Novilase 100001-02
GUDID 00860008944870
Novilase Laser Therapy System for focal destruction breast tumors. For distribution in Europe and Switzerland.
Novian Health Inc.
General/multiple surgical diode laser system| Primary Device ID | 00860008944870 |
| NIH Device Record Key | db8976ad-c21c-45fc-9816-447eb550b9e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Novilase |
| Version Model Number | LTS 2.1 (EU/Switzerland) |
| Catalog Number | 100001-02 |
| Company DUNS | 011736427 |
| Company Name | Novian Health 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 | true |
| 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 | 00860008944870 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160392
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
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 | 2023-11-23 |
| Device Publish Date | 2023-11-15 |
On-Brand Devices [Novilase]
| 00860008944825 | Novilase Laser Therapy System for focal destruction breast tumors. |
| 00860008944887 | Novilase Laser Therapy System for focal destruction breast tumors. For distribution in the UK. |
| 00860008944870 | Novilase Laser Therapy System for focal destruction breast tumors. For distribution in Europe an |
Trademark Results [Novilase]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVILASE 77407877 3755293 Live/Registered |
NOVIAN HEALTH INC. 2008-02-27 |
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