BluTube 180 Day Cartridge

GUDID 00850018182089

BluTube 180 Day Cartridge

PROEDGE DENTAL PRODUCTS, INC.

Dental water line disinfectant cartridge
Primary Device ID00850018182089
NIH Device Record Keye1c5166c-a05e-400f-a8f9-02f3d62bf83b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBluTube 180 Day Cartridge
Version Model NumberBT180
Company DUNS050414346
Company NamePROEDGE DENTAL PRODUCTS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com
Phone18888433343
Emailrichardv@proedgedental.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018182041 [Primary]
GS100850018182089 [Package]
Contains: 00850018182041
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

EIAUnit, Operative Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-18
Device Publish Date2020-05-08

Devices Manufactured by PROEDGE DENTAL PRODUCTS, INC.

00850018182089 - BluTube 180 Day Cartridge 2020-05-18BluTube 180 Day Cartridge
00850018182089 - BluTube 180 Day Cartridge 2020-05-18 BluTube 180 Day Cartridge
00850018182072 - BluTube 90 Day Cartridge 2020-05-18
00850018182003 - BluTab 2L Tablets2020-04-28
00850018182010 - BluTab 750mL Tablets2020-04-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.