GUDID 03700712405724

EPS 10U OR

MAQUET SAS

Operating room light

• Primary Device ID: 03700712405724
• NIH Device Record Key: b734f76f-ef93-4fde-9c6d-bc4e447b09e1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ARD567355938
• 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	03700712405724 [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

• 03700712432294 - Maquet Ezea: 2024-11-26 EZEA30SF W07
• 03700712432300 - Maquet Ezea: 2024-11-26 EZEA30SF TK W07
• 03700712432317 - Maquet Ezea: 2024-11-26 EZEA30DF TK W08
• 03700712432720 - Maquet Ezea: 2024-11-26 EZEA30DF W08
• 03700712412029 - Maquet Rolite: 2024-11-15 ROL PWDII70SF AIM CL K3
• 03700712413897 - Maquet PowerLED II: 2024-11-15 PWDII70DF VP AIM XS3216 K3 1011
• 03700712413903 - Maquet PowerLED II: 2024-11-15 PWDII50DF AIM XS3216 K3 1011
• 03700712414641 - Maquet PowerLED II: 2024-11-15 PWDII70SF VP AIM CL XS3216 K3 1011