VENUS Diamond FLOW 66100275

GUDID J014661002750

VENUS Diamond FLOW PLT 20x0,20g - BLEACH

Kulzer GmbH

Dental composite resin
Primary Device IDJ014661002750
NIH Device Record Key084b672f-c8cd-48a1-98fc-2f5157f86e6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENUS Diamond FLOW
Version Model Number66100275
Catalog Number66100275
Company DUNS315666321
Company NameKulzer GmbH
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 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

Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx
Phone+1(800)431-1785
Emailxxx@xxx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ014661002750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBCSEALANT, PIT AND FISSURE, AND CONDITIONER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-01
Device Publish Date2024-10-24

On-Brand Devices [VENUS Diamond FLOW]

J014661003060PROC Venus Diamond Flow Kit 2x1.8G SYR
J014661002750VENUS Diamond FLOW PLT 20x0,20g - BLEACH
J014661002740VENUS Diamond FLOW PLT 20x0,20g - DARK
J014661002730VENUS Diamond FLOW PLT 20x0,20g - MEDIUM
J014661002720VENUS Diamond FLOW PLT 20x0,20g - LIGHT
J014661002710VENUS Diamond FLOW SYR 1 x 1,8G - BLEACH
J014661002700VENUS Diamond FLOW SYR 1 x 1,8G - DARK
J014661002690VENUS Diamond FLOW SYR 1 x 1,8G - MEDIUM
J014661002680VENUS Diamond FLOW SYR 1 x 1,8G - LIGHT

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