VENUS Diamond FLOW SYR 1 x 1,8G - A2 66040355

GUDID J014660403550

sealant, pit and fissure and conditionar

Kulzer GmbH

Dental pit/fissure sealant
Primary Device IDJ014660403550
NIH Device Record Keyb14fed6d-a28e-4fc0-b26e-9c234c51795b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENUS Diamond FLOW SYR 1 x 1,8G - A2
Version Model Number66040355
Catalog Number66040355
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.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ014660403550 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-10-30
Device Publish Date2016-09-15

Devices Manufactured by Kulzer GmbH

J014661002680 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - LIGHT
J014661002690 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - MEDIUM
J014661002700 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - DARK
J014661002710 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - BLEACH
J014661002720 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - LIGHT
J014661002730 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - MEDIUM
J014661002740 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - DARK
J014661002750 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - BLEACH

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