POWERLED

GUDID 03700712405830

PWD70+DF HOR SC07 K3

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 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 Operating room light Operating room light Operating room light

• Primary Device ID: 03700712405830
• NIH Device Record Key: d5cd85f0-0e84-4570-b7c0-4a3777169f09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWERLED
• Version Model Number: ARDPWD219010A
• 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	03700712405830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070442

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: 2017-03-17

On-Brand Devices [POWERLED]

• 03700712405830: PWD70+DF HOR SC07 K3
• 03700712405823: PWD70+DF HOR R K3
• 03700712406103: PWD33 S SHELTER
• 03700712421113: PWD33S SHELTER RETROFIT KIT