MIRA Minor Surgery Light L-MLED65-FS-XX-EX

GUDID 00667774000133

Mira LED 65, Floorstand, Extended Arm

Amico Lights Corporation

Fixed examination/treatment light

• Primary Device ID: 00667774000133
• NIH Device Record Key: b675602a-ccd9-4137-b299-5a1161b9f131
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRA Minor Surgery Light
• Version Model Number: MIRA
• Catalog Number: L-MLED65-FS-XX-EX
• Company DUNS: 203021407
• Company Name: Amico Lights Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com
• Phone: (905) 764-0800
• Email: ekotyk@amico.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00667774000133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131893

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-09

On-Brand Devices [MIRA Minor Surgery Light]

• 00667774000249: Mira LED 90, Wall Mount, Standard Arm
• 00667774000232: Mira LED 90, Wall Mount, Extended Arm
• 00667774000225: Mira LED 90, Floorstand, Standard Arm
• 00667774000218: Mira LED 90, Floorstand, Extended Arm
• 00667774000201: Mira LED 90, Ceiling Mount, Single, Standard Arm
• 00667774000195: Mira LED 90, Ceiling Mount, Single, Extended Arm
• 00667774000188: Mira LED 90, Ceiling Mount, Double, Standard Arm
• 00667774000171: Mira LED 90, Ceiling Mount, Double, Extended Arm
• 00667774000164: Mira LED 90, Wall Mount, Standard Arm
• 00667774000157: Mira LED 90, Wall Mount, Extended Arm
• 00667774000140: Mira LED 65, Floorstand, Standard Arm
• 00667774000133: Mira LED 65, Floorstand, Extended Arm
• 00667774000126: Mira LED 65, Ceiling Mount, Single, Standard Arm
• 00667774000119: Mira LED 65, Ceiling Mount, Single, Extended Arm
• 00667774000102: Mira LED 65, Ceiling Mount, Double, Standard Arm
• 00667774000096: Mira LED 65, Ceiling Mount, Double, Extended Arm
• 00667774000089: Mira LED 50, Wall Mount, Standard Arm
• 00667774000072: Mira LED 50, Wall Mount, Extended Arm
• 00667774000065: Mira LED 50, Floorstand, Standard Arm
• 00667774000058: Mira LED 50, Floorstand, Extended Arm
• 00667774000041: Mira LED 50, Ceiling Mount, Single, Standard Arm
• 00667774000034: Mira LED 50, Ceiling Mount, Single, Extended Arm
• 00667774000027: Mira LED 50, Ceiling Mount, Double, Standard Arm
• 00667774000010: Mira LED 50, Ceiling Mount, Double, Extended Arm