FDA.reportPublic FDA data

ENTERRA ™

Primary DI
00643169887589
Brand
ENTERRA ™
Company
MEDTRONIC, INC.
Model
4351-35
Device description
LEAD 4351-35 ENTERRA GASTRIC EMAN FWU
Published
2017-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNQintestinal Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNQIntestinal StimulatorUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H990014129

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H990014129

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169887589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169887589006431698875896431698875890643169887589

GMDN Terms#

Term, Definition table
TermDefinition
Gastric electrical stimulation systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850045965204Enterra ReliaStim Unipolar LeadEnterra Medical, Inc.LNQ2026-01-13
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
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