Enterra ReliaStim Unipolar Lead 30101

GUDID 00850045965204

The ReliaStim lead is a sterile, single-use device designed for permanent implantation as a part of the Enterra gastric electrical stimulation system.

Enterra Medical, Inc.

Gastric electrical stimulation system

• Primary Device ID: 00850045965204
• NIH Device Record Key: 88ff6ed2-d381-4e19-9504-222a3d74948d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enterra ReliaStim Unipolar Lead
• Version Model Number: 30101
• Catalog Number: 30101
• Company DUNS: 118781894
• Company Name: Enterra Medical, Inc.
• 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	00850045965204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H990014

FDA Product Code

• LNQ: Intestinal Stimulator

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: 2026-01-21
• Device Publish Date: 2026-01-13