Cluster Applicator 5402 5402

GUDID 00816864020555

660/950 nm SLD/LED cluster applicator

METTLER ELECTRONICS CORP.

Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional

• Primary Device ID: 00816864020555
• NIH Device Record Key: 719ea96a-3c47-4973-a49e-cc869de937cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cluster Applicator 5402
• Version Model Number: 5402
• Catalog Number: 5402
• Company DUNS: 008513913
• Company Name: METTLER ELECTRONICS CORP.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816864020555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043586

FDA Product Code

• ILY: Lamp, infrared, therapeutic heating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-15

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