GUDID 03700712405731

EPS 20U OR

MAQUET SAS

Operating room light

• Primary Device ID: 03700712405731
• NIH Device Record Key: c1d50457-a31e-410e-be5c-4a1b9d2da6ad
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ARD567355939
• 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	03700712405731 [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: 2021-01-08
• Device Publish Date: 2017-02-27

Devices Manufactured by MAQUET SAS

• 03700712434526 - Maquet PowerLED II: 2025-09-11 PWDII70DF VP4K K4 SAX14
• 03700712435851 - Maquet PowerLED II: 2025-09-11 PWDII75DF VP4K K3 SAX1012
• 03700712436063 - Maquet PowerLED II: 2025-09-11 PWDII775DF 2VP CL K3 081012
• 03700712436087 - Maquet PowerLED II: 2025-09-11 PWDII55DF K3 XO SAX081012
• 03700712434540 - Volista: 2025-06-13 VCSII60SF SAX12
• 03700712434557 - Volista: 2025-06-13 VCSII60DF SAX08
• 03700712434564 - Volista: 2025-06-13 VCSII66SF SAX1012
• 03700712434571 - Volista: 2025-06-13 VCSII66DF SAX0810