VarioSurg
GUDID 04560264563087
NAKANISHI INC.
Dental ultrasonic surgical system handpiece tip| Primary Device ID | 04560264563087 |
| NIH Device Record Key | f5b6d899-caf2-49b3-93c3-9b4f7c836bf1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VarioSurg |
| Version Model Number | SG16A |
| Company DUNS | 690710546 |
| Company Name | NAKANISHI 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 | 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04560264563087 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073678
FDA Product Code
| ELC | Scaler, ultrasonic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
[04560264563087]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-16 |
On-Brand Devices [VarioSurg]
| 04560264563957 | H-SG8L |
| 04560264563940 | H-SG8R |
| 04560264563933 | SG68 |
| 04560264563902 | SCL4D |
| 04560264563896 | SCL2D |
| 04560264563872 | SCL3 |
| 04560264563865 | SCL1D |
| 04560264563858 | SCL1 |
| 04560264563841 | H-SG1 |
| 04560264563834 | SCL5D |
| 04560264563827 | SCL5 |
| 04560264563810 | SCL3D |
| 04560264563803 | H-SG8 |
| 04560264563797 | SG58 |
| 04560264563674 | VarioSurg Unit |
| 04560264563667 | VarioSurg Unit |
| 04560264563650 | VarioSurg Unit |
| 04560264563643 | SG8A |
| 04560264563636 | SG1A |
| 04560264563605 | SG30 |
| 04560264563599 | SG18L |
| 04560264563582 | SG18R |
| 04560264563575 | SG15D |
| 04560264563568 | SG15C |
| 04560264563124 | V10-S |
| 04560264563117 | SG19 |
| 04560264563100 | SG17 |
| 04560264563094 | SG16B |
| 04560264563087 | SG16A |
| 04560264563070 | SG15B |
| 04560264563063 | SG15A |
| 04560264562936 | SG14L |
| 04560264562929 | SG14R |
| 04560264562912 | E32D-S |
| 04560264562905 | E31D-S |
| 04560264562899 | E30LD-S |
| 04560264562882 | E30RD-S |
| 04560264562875 | P25L-S |
| 04560264562868 | P25R-S |
| 04560264562851 | P20-S |
| 04560264562844 | G1-S |
| 04560264562837 | SG11 |
| 04560264562820 | SG10 |
| 04560264562813 | SG9 |
| 04560264562806 | SG8 |
| 04560264562790 | SG7D |
| 04560264562783 | SG6D |
| 04560264562776 | SG5 |
| 04560264562769 | SG4 |
| 04560264562752 | SG3 |
Trademark Results [VarioSurg]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VARIOSURG 78889036 3542014 Live/Registered |
NAKANISHI INC. 2006-05-22 |
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