AURAWAVE

GUDID 00628055644002

T.E.N.S. Device ; Pain Relief Therapy Kit.

ENDURANCE THERAPEUTICS INC.

Arthritis TENS system Arthritis TENS system

• Primary Device ID: 00628055644002
• NIH Device Record Key: 490fdbe2-b0f4-47fb-b45b-e3e3e76db098
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AURAWAVE
• Version Model Number: AWDD
• Company DUNS: 963843318
• Company Name: ENDURANCE THERAPEUTICS INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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: true

Customer Support Contacts

• Phone: 888.358.7145
• Email: support@pmafulfillment.com
• Phone: 888.358.7145
• Email: support@pmafulfillment.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055644002 [Primary]

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2019-03-11
• Device Publish Date: 2016-10-28