Toothprint Wafer

GUDID 00858290006284

Toothprint Wafer Kit-48pk

ELEVATE ORAL CARE, LLC

Saliva absorbent
Primary Device ID00858290006284
NIH Device Record Key28492473-72e5-4669-80a4-9b44e7182f48
Commercial Distribution StatusIn Commercial Distribution
Brand NameToothprint Wafer
Version Model Number660000480
Company DUNS002863526
Company NameELEVATE ORAL CARE, LLC
Device Count48
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100858290006284 [Primary]
GS100858290006291 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EGDWax, Dental, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-28
Device Publish Date2019-01-28

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