Enterra ReliaStim Unipolar Lead 30101

by Enterra Medical, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850045965204 UDI-DI	Date13 Jan 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name: Enterra ReliaStim Unipolar Lead
Generic Name: Gastric electrical stimulation system
Model / Ref / Catalog: 30101

Primary DI / UDI-DI: 00850045965204
PMA Number: H990014
FDA Product Code: LNQ
GMDN Term: Gastric electrical stimulation system

Device Class: Unclassified
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Conditional

Properties

Sterile
Single Use
Implantable
Prescription Use
Serial Number
Expiration Date
Manufacturing Date

Other properties (7)

Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No