FDA.reportPublic FDA data

ENTERRA®

Primary DI
00643169936577
Brand
ENTERRA®
Company
MEDTRONIC, INC.
Model
4351-35
Device description
LEAD 4351-35 ENTERRA GASTRIC EMAN FWU
Published
2018-04-19
Public version status
Update
Distribution status
Not 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
H990014139

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H990014139

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169936577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169936577006431699365776431699365770643169936577

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
796986144
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000354466Symplicity Spyral™RDN0162023-11-30
00613994391551NA6207-S52017-01-03
00613994391568NA6208-S52017-01-03
00613994391575NA6209-S52017-01-03
00613994391582NA6210-S52017-01-03
00613994397829NA6211-S52017-01-03
00643169002913Stretch™ Insertion Tool0060732016-07-02
00643169013964NA2082112017-02-02
00643169013988NA2072232017-02-03
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014022NA2062232017-02-03
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850045965020Enterra IIEnterra Medical, Inc.LNQ2026-10-16
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
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