Harmony

GUDID 00724995151461

Ceiling supported surgical lighting system consisting of one or more LED lightheads.

STERIS CORPORATION

Operating light system

• Primary Device ID: 00724995151461
• NIH Device Record Key: 0ff73e6d-e246-4240-ba35-488ff30a356b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony
• Version Model Number: LED Surgical Lighting System
• Company DUNS: 036985604
• Company Name: STERIS 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: 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

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995151461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072072

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: 2016-09-06

On-Brand Devices [Harmony]

• 00724995151478: Ceiling supported surgical lighting system consisting of one or more vLED lightheads.
• 00724995151461: Ceiling supported surgical lighting system consisting of one or more LED lightheads.
• 00724995154646: The Harmony LED Monitor Arm Adapter is used with the Harmony LA, LED and HarmonyAIR M-Series Su