FDA.reportPublic FDA data

Enterra ReliaStim Unipolar Lead

Primary DI
00850045965204
Brand
Enterra ReliaStim Unipolar Lead
Company
Enterra Medical, Inc.
Model
30101
Catalog number
30101
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.
Published
2026-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LNQIntestinal Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNQIntestinal StimulatorUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H990014229

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H990014229

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045965204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045965204008500459652048500459652040850045965204

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118781894
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045965020Enterra II37800378002026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850045965020Enterra IIEnterra Medical, Inc.LNQ2026-10-16
00763000875862N'VISION™MEDTRONIC, INC.LNQ2023-11-16
00763000449704Enterra® IIMEDTRONIC, INC.LNQ2021-05-28
00763000315443N'VisionMEDTRONIC, INC.LNQ2020-08-13
00763000286798ENTERRA® IIMEDTRONIC, INC.LNQ2020-06-29
00763000129514N'VISION®MEDTRONIC, INC.LNQ2019-05-19
00643169936577ENTERRA®MEDTRONIC, INC.LNQ2018-04-19
00643169866218N'VISION™MEDTRONIC, INC.LNQ2017-10-02
00643169887589ENTERRA ™MEDTRONIC, INC.LNQ2017-09-09
00643169572072N'VISION®MEDTRONIC, INC.LNQ2017-04-07
00643169614246ENTERRA® IIMEDTRONIC, INC.LNQ2016-07-11
00643169360686Enterra® IIMEDTRONIC, INC.LNQ2014-10-03
00643169427037N'VISION®MEDTRONIC, INC.LNQ2014-09-29
00643169174993ENTERRA®MEDTRONIC, INC.LNQ2014-09-23
00643169175006ENTERRA ™MEDTRONIC, INC.LNQ2014-09-23
00613994997838N'VISION™MEDTRONIC, INC.LNQ2014-09-23
00613994997845N'VISION™MEDTRONIC, INC.LNQ2014-09-23
00613994452191N'VISION®MEDTRONIC, INC.LNQ2014-09-23
00613994572783N'VISION®MEDTRONIC, INC.LNQ2014-09-23
00613994606846N'VISION®MEDTRONIC, INC.LNQ2014-09-23