GUDID 03700712414023

EPS 22 C V2

MAQUET SAS

Operating room light

• Primary Device ID: 03700712414023
• NIH Device Record Key: d420434c-5f96-4d37-934a-bec026d53052
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ARD567355961
• 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	03700712414023 [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: 2
• Public Version Date: 2021-01-08
• Device Publish Date: 2019-01-21

Devices Manufactured by MAQUET SAS

• 03700712414283 - Maquet Equipment: 2025-01-14 EQTXS3216 SAT12
• 03700712414290 - Maquet Equipment: 2025-01-14 EQTXS3216 SAT13
• 03700712414306 - Maquet Equipment: 2025-01-14 EQTXS3216 11
• 03700712415662 - Volista: 2025-01-14 VST66SF VP TK AIM 1011
• 03700712415693 - Volista: 2025-01-14 VST64DF VP TK AIM 0810
• 03700712432713 - Volista: 2025-01-13 VCSII64SFDF SB1011
• 03700712433055 - Volista: 2025-01-13 VSTII40DF FHS019 SAX1012
• 03700712433062 - Volista: 2025-01-13 VSTII40DF MHS019 SAX1012