ASA srl F9000221

GUDID 08033765391016

ASA SRL

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 08033765391016
• NIH Device Record Key: 5b231c98-6d73-4bab-9419-03539957247f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASA srl
• Version Model Number: Mphi
• Catalog Number: F9000221
• Company DUNS: 429533573
• Company Name: ASA SRL
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033765391016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111901

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: 2025-04-18
• Device Publish Date: 2016-09-21

On-Brand Devices [ASA srl]

• 08033765391023: Mphi D
• 08033765391016: Mphi
• 08033765391009: M6