RVG 6100 5155114

GUDID 60192155155116

RVG 6100 - SIZE 0

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: 60192155155116
• NIH Device Record Key: 0134a1ab-59c8-442e-8d3e-97633788bc5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RVG 6100
• Version Model Number: RVG 6100
• Catalog Number: 5155114
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192155155116 [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: 6
• Public Version Date: 2020-02-10
• Device Publish Date: 2018-01-15

On-Brand Devices [RVG 6100]

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