ROLITE VOLISTA STANDOP

GUDID 03700712400897

VST60 TK AIM ROL

MAQUET SAS

Medical monitor/light stand

• Primary Device ID: 03700712400897
• NIH Device Record Key: 716804f4-d121-4d6e-845b-2d8c00f2e5f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROLITE VOLISTA STANDOP
• Version Model Number: ARDROL309021A
• 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	03700712400897 [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 STANDOP]

• 03700712400903: VST60 TK AIM ROL B
• 03700712400897: VST60 TK AIM ROL
• 03700712400880: VST60 AIM ROL B
• 03700712400873: VST60 AIM ROL
• 03700712400866: VST40 TK AIM ROL B
• 03700712400859: VST40 TK AIM ROL
• 03700712400842: VST40 AIM ROL B
• 03700712400835: VST40 AIM ROL