Harmony

GUDID 00724995151461

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

STERIS CORPORATION

Operating light system Operating light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room 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