RVG 5200 CIC48

GUDID 60192155008108

CAPTEUR RVG 5200 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	60192155008108
NIH Device Record Key	6fb86a75-3699-44ab-b110-164f96ceb42c
Commercial Distribution Status	In Commercial Distribution
Brand Name	RVG 5200
Version Model Number	RVG 5200
Catalog Number	CIC48
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	60192155008108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K950532

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 5200]

60192155311307	RVG 5200 SIZE 2
60192155311291	RVG 5200 SIZE 1
60192155008108	CAPTEUR RVG 5200 T2 CSD
60192155008092	CAPTEUR RVG 5200 T1 CSD