POWERLED

GUDID 03700712405823

PWD70+DF HOR R K3

MAQUET SAS

Operating room light

• Primary Device ID: 03700712405823
• NIH Device Record Key: cd8579a8-8a74-49e6-8f91-726a2d0d2c0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWERLED
• Version Model Number: ARDPWD209051A
• 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	03700712405823 [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