Enterra ReliaStim Unipolar Lead

Basic Information

• Brand Name: Enterra ReliaStim Unipolar Lead
• Primary DI: 00850045965204
• Version / Model: 30101
• Catalog Number: 30101
• Company Name: Enterra Medical, Inc.
• Labeler DUNS: 118781894
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-13
• Public Version: 1
• Public Version Date: 2026-01-21
• Public Version Status: New
• Public Device Record Key: 88ff6ed2-d381-4e19-9504-222a3d74948d

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNQ	Intestinal Stimulator	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
48001	Gastric electrical stimulation system	An assembly of devices designed to treat chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis through gastric electrical stimulation (GES) of the lower stomach (antrum). The assembly typically includes a battery-powered implantable pulse generator that produces the electrical stimuli delivered via implantable leads, and an external programmer that enables healthcare personnel to telemetrically modify the GES signal parameters of the pulse generator.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850045965204	GS1

Premarket Submissions

Submission Number	Supplement Number
H990014	229