ProphyCare HAp

GUDID 17310231029993

ProphyCare HAp in single dose disposable cups

Directa AB

Dentifrice
Primary Device ID17310231029993
NIH Device Record Keyf3972ab8-76b8-4428-a5ff-f303ca0a4a04
Commercial Distribution StatusIn Commercial Distribution
Brand NameProphyCare HAp
Version Model Number690108
Company DUNS353954381
Company NameDirecta AB
Device Count144
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+46850650575
Emailinfo@directadental.com
Phone+46850650575
Emailinfo@directadental.com
Phone+46850650575
Emailinfo@directadental.com
Phone+46850650575
Emailinfo@directadental.com
Phone+46850650575
Emailinfo@directadental.com
Phone+46850650575
Emailinfo@directadental.com
Phone+46850650575
Emailinfo@directadental.com
Phone+46850650575
Emailinfo@directadental.com
Phone+46850650575
Emailinfo@directadental.com
Phone+46850650575
Emailinfo@directadental.com
Phone+46850650575
Emailinfo@directadental.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS117310231029993 [Unit of Use]
GS117310236901089 [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 Date2025-09-09
Device Publish Date2025-09-01

On-Brand Devices [ProphyCare HAp]

17310237311177Blue
17310231029993ProphyCare HAp in single dose disposable cups

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