Home GUDID 00850045965020 Enterra II
Primary DI 00850045965020
Brand Enterra II
Company Enterra Medical, Inc.
Model 37800
Catalog number 37800
Device description The Enterra II neurostimulator is a sterile, single-use device designed for permanent implantation as a part of the Enterra gastric electrical stimulation system.
Published 2026-10-16
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name LNQ Intestinal Stimulator
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LNQ Intestinal Stimulator Unknown f
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850045965020 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850045965020 00850045965020 850045965020 0850045965020
GMDN Terms# Term, Definition table Term Definition 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.
Device Sizes# Type, Value, Unit table Type Value Unit Height 0 Length 0 Total Volume 0 Weight 0
Regulatory Flags# DUNS number 118781894 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850045965204 Enterra ReliaStim Unipolar Lead 30101 30101 2026-01-13
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850045965204 Enterra ReliaStim Unipolar Lead Enterra Medical, Inc. LNQ 2026-01-13 00763000875862 N'VISION™ MEDTRONIC, INC. LNQ 2023-11-16 00763000449704 Enterra® II MEDTRONIC, INC. LNQ 2021-05-28 00763000315443 N'Vision MEDTRONIC, INC. LNQ 2020-08-13 00763000286798 ENTERRA® II MEDTRONIC, INC. LNQ 2020-06-29 00763000129514 N'VISION® MEDTRONIC, INC. LNQ 2019-05-19 00643169936577 ENTERRA® MEDTRONIC, INC. LNQ 2018-04-19 00643169866218 N'VISION™ MEDTRONIC, INC. LNQ 2017-10-02 00643169887589 ENTERRA ™ MEDTRONIC, INC. LNQ 2017-09-09 00643169572072 N'VISION® MEDTRONIC, INC. LNQ 2017-04-07 00643169614246 ENTERRA® II MEDTRONIC, INC. LNQ 2016-07-11 00643169360686 Enterra® II MEDTRONIC, INC. LNQ 2014-10-03 00643169427037 N'VISION® MEDTRONIC, INC. LNQ 2014-09-29 00643169174993 ENTERRA® MEDTRONIC, INC. LNQ 2014-09-23 00643169175006 ENTERRA ™ MEDTRONIC, INC. LNQ 2014-09-23 00613994997838 N'VISION™ MEDTRONIC, INC. LNQ 2014-09-23 00613994997845 N'VISION™ MEDTRONIC, INC. LNQ 2014-09-23 00613994452191 N'VISION® MEDTRONIC, INC. LNQ 2014-09-23 00613994572783 N'VISION® MEDTRONIC, INC. LNQ 2014-09-23 00613994606846 N'VISION® MEDTRONIC, INC. LNQ 2014-09-23