ProphyCare Hap 731117

GUDID 17310237311177

Directa AB

Dentifrice
Primary Device ID17310237311177
NIH Device Record Keyfd267e41-40b3-41c4-806b-2c998be243f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameProphyCare Hap
Version Model NumberBlue
Catalog Number731117
Company DUNS353954381
Company NameDirecta AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS117310237311177 [Primary]

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 Date2022-12-14
Device Publish Date2022-12-06

On-Brand Devices [ProphyCare Hap]

17310237311177Blue
17310231029993ProphyCare HAp in single dose disposable cups

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