ENTERRA ™

Primary DI
00643169175006
Brand
ENTERRA ™
Company
MEDTRONIC, INC.
Model
4351-35
Device description
LEAD 4351-35 ENTRRA 35CM SPTTR WIRE eMAN
Published
2014-09-23
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
H990014069

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H990014069

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169175006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169175006006431691750066431691750060643169175006

GMDN Terms#

Term, Definition table
TermDefinition
Neural-tissue electrical stimulation leadA sterile metal wire, insulated with non-conductive material except at its electrode(s), intended to be implanted in neural tissue to enable an electrical connection typically with an external pulse generator (EPG) [e.g., a spinal cord stimulation (SCS) or a deep brain stimulation (DBS) stimulator] that will provide the required tissue stimulation.

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
006261481
Device count
1
Serial number
true

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00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
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00824846003472NABB10L84R92026-07-04
00824846003687NABB4K20R42026-07-04
00824846003700NABB4645R212026-07-04
00824846001669NABB12T12R42026-06-28
00824846001843NA9S63R22026-06-28
00824846001850NA11U35R32026-06-28
00824846001614NABB12V43R32026-06-25
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08

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
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
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