Blu-Mousse® S439K

GUDID 10810000526984

Mixing Tip for Standard Cartridge for use with Blu-Mousse® (Pkg. of 30 pcs.)

PARKELL, INC.

Dental material mixing nozzle, non-sterile
Primary Device ID10810000526984
NIH Device Record Keyf9ec201c-c48f-466a-b7cb-f185127a8a60
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlu-Mousse®
Version Model NumberS439K
Catalog NumberS439K
Company DUNS009900424
Company NamePARKELL, INC.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
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
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000526987 [Unit of Use]
GS110810000526984 [Primary]

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-03
Device Publish Date2018-09-21

On-Brand Devices [Blu-Mousse®]

M595S4360Tubes of Classic Blu-Mousse®
M595S4571Super-Fast Blu-Mousse® Standard-Cartridge System
M595S448S1Peppermint Super-Fast Blu-Mousse® In Split-Cartridge System
M595S440S1Blu-Mousse® 60 In Split-Cartridge
M595S4381Classic Blu-Mousse® Standard-Cartridge System
M595S437S1Peppermint Classic Blu-Mousse® In Split-Cartridge System
M595S457S0Super-Fast Blu-Mousse® Split-Cartridge System
M595S438S0Classic Blu-Mousse® In Split-Cartridge System
00810000524211Super-Fast Blu-Mousse® Standard-Cartridge System (Korea)
00810000524167Classic Blu-Mousse® in Standard Cartridges (Korea)
00810000524228Super-Fast Blu-Mousse® Split-Cartridge System (Korea)
00810000524181Blu-Mousse® 60 In Split-Cartridge (Korea)
00810000524174Classic Blu-Mousse® In Split-Cartridge System (Korea)
00810000524501Tubes of Classic Blu-Mousse® (Korea)
10810000526984Mixing Tip for Standard Cartridge for use with Blu-Mousse® (Pkg. of 30 pcs.)
10810000526977Snap-In Intraoral Tip for Use in S439K, S445 & S496 Mixing Tips (Pkg. of 50 pcs.)
10810000524218Super-Fast Blu-Mousse® Standard-Cartridge System
10810000524164Classic Blu-Mousse® Cartridges
10810000524195Peppermint Super-Fast Blu-Mousse® In Split-Cartridge System
10810000524188Blu-Mousse® 60 In Split-Cartridge
10810000524157Peppermint Classic Blu-Mousse® In Split-Cartridge System

Trademark Results [Blu-Mousse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BLU-MOUSSE
BLU-MOUSSE
73685563 1486672 Live/Registered
PARKELL PRODUCTS INC.
1987-09-21

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