eCoin Device Kit 1011-2447

GUDID 00860007896903

eCoin Device Kit

Valencia Technologies Corporation

Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system Tibial nerve implantable incontinence-control electrical stimulation system

• Primary Device ID: 00860007896903
• NIH Device Record Key: 82b6ef53-182a-447d-b53d-df13473d2e14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eCoin Device Kit
• Version Model Number: 1011-2447
• Catalog Number: 1011-2447
• Company DUNS: 968538988
• Company Name: Valencia Technologies Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007896903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200036

FDA Product Code

• QPT: Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-06
• Device Publish Date: 2022-04-28

Devices Manufactured by Valencia Technologies Corporation

• 00860007896972 - eCoin External Controller Kit: 2023-05-05 eCoin External Controller Kit
• 00860007896903 - eCoin Device Kit: 2022-05-06eCoin Device Kit
• 00860007896903 - eCoin Device Kit: 2022-05-06 eCoin Device Kit
• 00860007896910 - eCoin External Controller Kit: 2022-05-06 eCoin External Controller Kit
• 00860007896927 - eCoin Procedural Kit: 2022-05-06 eCoin Procedural Kit
• 00860007896941 - eCoin Aftercare Kit: 2022-05-06 eCoin Aftercare Kit
• 00860007896958 - eCoin Explant Kit: 2022-05-06 eCoin Explant Kit
• 00860007896965 - eCoin Patient Kit: 2022-05-06 eCoin Patient Kit