Visalys Restorative Primer 13581

GUDID E217135811

Visalys Restorative Primer

Kettenbach GmbH & Co. KG

Dental prosthesis priming agent
Primary Device IDE217135811
NIH Device Record Keyc2ba47ca-4513-4be4-9899-e479b5d53c48
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisalys Restorative Primer
Version Model Number13581
Catalog Number13581
Company DUNS316803246
Company NameKettenbach GmbH & Co. KG
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE217135811 [Primary]

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-03
Device Publish Date2019-11-25

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