TurboSENSOR™ D560-110E

GUDID 00810000520534

TurboSENSOR™ Ultrasonic Scaler 110 Volt

PARKELL, INC.

Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system
Primary Device ID00810000520534
NIH Device Record Keye832c5f6-bef6-4f76-92e1-ce6d9ec55844
Commercial Distribution StatusIn Commercial Distribution
Brand NameTurboSENSOR™
Version Model NumberD560-110E
Catalog NumberD560-110E
Company DUNS009900424
Company NamePARKELL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000520534 [Primary]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-17
Device Publish Date2020-02-07

On-Brand Devices [TurboSENSOR™]

00810000520541TurboSENSOR™ Ultrasonic Scaler 230 Volt
00810000520527TurboSENSOR™ Ultrasonic Scaler 110 Volt
M595D5601100TurboSENSOR™ Ultrasonic Scaler 110 Volt
00810000520534TurboSENSOR™ Ultrasonic Scaler 110 Volt
00810000520350TurboSENSOR® Ultrasonic Scaler 110 Volt with 54" Cable

Trademark Results [TurboSENSOR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TURBOSENSOR
TURBOSENSOR
87217880 5214047 Live/Registered
Parkell, Inc.
2016-10-27

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