GUDID 03700712413958

EPS 12 TR V2

MAQUET SAS

Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light

• Primary Device ID: 03700712413958
• NIH Device Record Key: e770fbfe-9e35-46a2-82e4-243a59a720b6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ARD567355954
• 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	03700712413958 [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

• 03700712434212 - Maquet PowerLED II: 2024-03-15 PWDII75DF VP CL K4 SAX1012
• 03700712434229 - Maquet PowerLED II: 2024-03-15 PWDII75DF VP4K CL K4 SAX1012
• 03700712421403 - Maquet Equipment: 2024-03-13 EQTFHS019 SAX12
• 03700712422455 - Maquet Equipment: 2024-03-13 EQTFHS019 SATX15
• 03700712422462 - Maquet Equipment: 2024-03-13 EQTFHS019 SATX13
• 03700712432973 - Volista: 2024-03-07 VSTII40DF VP TK SAX12
• 03700712432980 - Volista: 2024-03-07 VSTII40DF VP TK SAX16
• 03700712432997 - Volista: 2024-03-07 VSTII60DF VP TK SAX12