RVG 5100 CIC52

GUDID 60192155008160

CAPTEUR RVG 5100 T2 CSD

CARESTREAM DENTAL LLC

Dental digital imaging sensor, intraoral

• Primary Device ID: 60192155008160
• NIH Device Record Key: abda92b6-6681-47d6-9a8a-d236d6a60971
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RVG 5100
• Version Model Number: RVG 5100
• Catalog Number: CIC52
• 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	60192155008160 [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 5100]

• 60192155008160: CAPTEUR RVG 5100 T2 CSD
• 60192155008016: CAPTEUR RVG 5100 T1 CSD