StimTrial Surgical Kit

GUDID 00816986020556

BIOVENTUS LLC

Analgesic PENS system

• Primary Device ID: 00816986020556
• NIH Device Record Key: 8294ac71-dc2b-44ff-bde3-fa52588aab5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StimTrial Surgical Kit
• Version Model Number: TS-1000
• Company DUNS: 078450878
• Company Name: BIOVENTUS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816986020556 [Primary]

FDA Product Code

• GZF: Stimulator, Peripheral Nerve, Implanted (Pain Relief)

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: 2025-09-09
• Device Publish Date: 2025-09-01

Devices Manufactured by BIOVENTUS LLC

• 00816986020549 - TalisMann Implant Kit: 2025-09-09
• 00816986020556 - StimTrial Surgical Kit: 2025-09-09
• 00816986020556 - StimTrial Surgical Kit: 2025-09-09
• 00816986020570 - StimTrial Patient Kit: 2025-09-09
• 00816986020587 - StimTrial Stimulator Kit: 2025-09-09
• 00816986020617 - Bioventus User Kit: 2025-09-09
• 00816986020624 - Bioventus Clinician Kit: 2025-09-09
• 00816986020525 - Osteoamp Flowable Access Cannula: 2024-11-29 The Allograft Delivery Device consists of a cannula and push rod made of biocompatible polypropylene. The device is provided ste
• 10389130444418 - SUPARTZ FX sodium hyaluronate: 2023-10-06 SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respon