DuraTip® DURA30-US

GUDID 00810000522927

30K DuraTip® Universal Slim Insert

PARKELL, INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Primary Device ID00810000522927
NIH Device Record Key11c6aa6f-34a2-407f-87e8-c5d3bf238feb
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraTip®
Version Model NumberDURA30-US
Catalog NumberDURA30-US
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 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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000522927 [Primary]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


[00810000522927]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-30
Device Publish Date2023-10-20

On-Brand Devices [DuraTip®]

0081000052292730K DuraTip® Universal Slim Insert
0081000052290330K DuraTip® Perio Slim Insert

Trademark Results [DuraTip]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DURATIP
DURATIP
90369249 not registered Live/Pending
Parkell, Inc.
2020-12-09
DURATIP
DURATIP
78409557 not registered Dead/Abandoned
CMI Connect, L.L.C.
2004-04-28
DURATIP
DURATIP
78383176 not registered Dead/Abandoned
Columbia Insurance Company
2004-03-12
DURATIP
DURATIP
76264662 2644283 Live/Registered
JEFFREY RADER CORPORATION
2001-05-31
DURATIP
DURATIP
76077206 2574419 Dead/Cancelled
HARROW SPORTS, INC.
2000-06-26
DURATIP
DURATIP
75450244 2259157 Dead/Cancelled
PACIFIC HANDY CUTTER, INC.
1998-03-13

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