Radent Prophy Paste Cups, Medium, Fresh Mint 13200

GUDID 00310866001265

Prophy Paste cups, 200 -1.23% fluoride ion with sodium phosphate, Fresh Mint flavor, Medium grit,

PASCAL COMPANY, INC.

Dentifrice
Primary Device ID00310866001265
NIH Device Record Keyeabeb572-2a8f-4d93-9bd9-563e26dfcbec
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadent Prophy Paste Cups, Medium, Fresh Mint
Version Model Number13200
Catalog Number13200
Company DUNS009260217
Company NamePASCAL COMPANY, INC.
Device Count200
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 Dimensions

Weight1.8 Gram

Operating and Storage Conditions

Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100310866001265 [Primary]
GS100310866001937 [Unit of Use]

FDA Product Code

EJRAgent, Polishing, Abrasive, Oral Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-01
Device Publish Date2019-01-29

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