DENTRA III 5944830

GUDID 60192155944833

DENTRA III SIZE 1

CARESTREAM DENTAL LLC

Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral
Primary Device ID60192155944833
NIH Device Record Key19daac89-5b05-4f8f-9bd6-0978d89b6254
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENTRA III
Version Model Number5944830
Catalog Number5944830
Company DUNS019796106
Company NameCARESTREAM DENTAL LLC
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS160192155944833 [Primary]

FDA Product Code

EAPUnit, X-Ray, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-12
Device Publish Date2023-06-02

On-Brand Devices [DENTRA III]

60192155944840DENTRA III SIZE 2
60192155944833DENTRA III SIZE 1

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