RVG 6100 5314166

GUDID 60192155314162

RVG 6100 - SIZE 0 w/o USB HUB

CARESTREAM DENTAL LLC

Dental digital imaging sensor, intraoral
Primary Device ID60192155314162
NIH Device Record Keyc99645f3-49d6-4d94-ae44-196b30cc6f6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRVG 6100
Version Model NumberRVG 6100
Catalog Number5314166
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS160192155314162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EAPUNIT, X-RAY, INTRAORAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-07
Device Publish Date2018-01-15

On-Brand Devices [RVG 6100]

60192155314162RVG 6100 - SIZE 0 w/o USB HUB
60192155155116RVG 6100 - SIZE 0
60192155008153CAPTEUR RVG 6100 T2 FLASH CSD
60192155008030CAPTEUR RVG 6100 T0 CSD
60192155008023CAPTEUR RVG 6100 T1 CSD

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