ROLITE VOLISTA ACCESS

GUDID 03700712400798

VCS40 ROL

MAQUET SAS

Medical monitor/light stand

• Primary Device ID: 03700712400798
• NIH Device Record Key: bc488d4f-e64b-4de0-be3d-eef21bdac4b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROLITE VOLISTA ACCESS
• Version Model Number: ARDROL309024A
• Company DUNS: 264700139
• Company Name: MAQUET SAS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700712400798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130513

FDA Product Code

• FSY: Light, surgical, ceiling mounted

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-16

On-Brand Devices [ROLITE VOLISTA ACCESS]

• 03700712400828: VCS60 ROL B
• 03700712400811: VCS60 ROL
• 03700712400804: VCS40 ROL B
• 03700712400798: VCS40 ROL