VarioSurg

GUDID 04560264563100

NAKANISHI INC.

Dental ultrasonic surgical system handpiece tip
Primary Device ID04560264563100
NIH Device Record Keyac4be45c-cadd-43b0-b606-c3136f824161
Commercial Distribution StatusIn Commercial Distribution
Brand NameVarioSurg
Version Model NumberSG17
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104560264563100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264563100]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-20
Device Publish Date2016-09-16

On-Brand Devices [VarioSurg]

04560264563957H-SG8L
04560264563940H-SG8R
04560264563933SG68
04560264563902SCL4D
04560264563896SCL2D
04560264563872SCL3
04560264563865SCL1D
04560264563858SCL1
04560264563841H-SG1
04560264563834SCL5D
04560264563827SCL5
04560264563810SCL3D
04560264563803H-SG8
04560264563797SG58
04560264563674VarioSurg Unit
04560264563667VarioSurg Unit
04560264563650VarioSurg Unit
04560264563643SG8A
04560264563636SG1A
04560264563605SG30
04560264563599SG18L
04560264563582SG18R
04560264563575SG15D
04560264563568SG15C
04560264563124V10-S
04560264563117SG19
04560264563100SG17
04560264563094SG16B
04560264563087SG16A
04560264563070SG15B
04560264563063SG15A
04560264562936SG14L
04560264562929SG14R
04560264562912E32D-S
04560264562905E31D-S
04560264562899E30LD-S
04560264562882E30RD-S
04560264562875P25L-S
04560264562868P25R-S
04560264562851P20-S
04560264562844G1-S
04560264562837SG11
04560264562820SG10
04560264562813SG9
04560264562806SG8
04560264562790SG7D
04560264562783SG6D
04560264562776SG5
04560264562769SG4
04560264562752SG3

Trademark Results [VarioSurg]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VARIOSURG
VARIOSURG
78889036 3542014 Live/Registered
NAKANISHI INC.
2006-05-22

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