Anodyne Therapy 498011

GUDID 00859101006097

ANODYNE THERAPY, L.L.C.

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 00859101006097
• NIH Device Record Key: 93c16211-d20a-4593-97b4-95134fe2b1ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anodyne Therapy
• Version Model Number: 120-2
• Catalog Number: 498011
• Company DUNS: 148751568
• Company Name: ANODYNE THERAPY, L.L.C.
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859101006097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931261

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-22

On-Brand Devices [Anodyne Therapy]

• 00859101006097: 120-2
• 00859101006066: Rally Back
• 00859101006059: 300
• 00859101006042: 480 Recertified
• 00859101006035: 480
• 00859101006028: 120 Professional
• 00859101006011: 120 Recertified
• 00859101006004: 120