RVG 6500 CIC43

GUDID 60192155008054

CAPTEUR RVG 6500 T2 CSD

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 Dental digital imaging sensor, intraoral

Primary Device ID	60192155008054
NIH Device Record Key	dd30f3fb-3672-4b59-85fd-cef63641ffba
Commercial Distribution Status	In Commercial Distribution
Brand Name	RVG 6500
Version Model Number	RVG 6500
Catalog Number	CIC43
Company DUNS	019796106
Company Name	CARESTREAM DENTAL LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192155008054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K093478

FDA Product Code

EAP	UNIT, X-RAY, INTRAORAL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-06-07
Device Publish Date	2018-01-15

On-Brand Devices [RVG 6500]

60192155008061	CAPTEUR RVG 6500 T0 CSD
60192155008054	CAPTEUR RVG 6500 T2 CSD
60192155008047	CAPTEUR RVG 6500 T1 CSD