FDA.reportPublic FDA data

PulseRider Aneurysm Neck Reconstruction Device Connection Cable

Primary DI
00859030005260
Brand
PulseRider Aneurysm Neck Reconstruction Device Connection Cable
Company
Medos International Sàrl
Model
PRDSACD
Catalog number
PRDSACD
Device description
PulseRider Aneurysm Neck Reconstruction Device Connection Cable
Published
2019-09-17
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
NJEIntracranial Neurovascular Stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJEIntracranial Neurovascular StentUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H160002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H160002000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859030005260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859030005260008590300052608590300052600859030005260

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002552500xx@xx.xx
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705028139NA2420552420552017-03-29
10886705030187NA2426322426322018-02-22
10886705030194NA2426332426332018-02-22
10886705030200NA2426342426342018-02-22
10886705030217NA2426352426352018-02-22
10886705030224NA2426362426362018-02-22
10886705030231NA2426372426372018-02-22
10886705030248NA2426382426382018-02-22
10886705030255NA2426392426392018-02-22
10886705030262NA2426402426402018-02-22
10886705030279NA2426522426522018-02-22
10886705030286NA2426532426532018-02-22
10886705030293NA2426542426542018-02-22
10705034606897TRIALTIS5560886545S5560886545S2026-05-29
10705034608679TRIALTIS5560520004S5560520004S2026-05-29
10705034608693TRIALTIS5560520310S5560520310S2026-05-29
10705034608709TRIALTIS5560520312S5560520312S2026-05-29
10705034608716TRIALTIS5560520002S5560520002S2026-05-29
10705034608723TRIALTIS5560520001S5560520001S2026-05-29
10705034608730TRIALTIS5560520003S5560520003S2026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859030005253PulseRiderMedos International SàrlNJE2019-09-17
00816777025982LVISMicrovention, Inc.NJE2018-11-25
00816777025999LVISMicrovention, Inc.NJE2018-11-25
00816777026002LVISMicrovention, Inc.NJE2018-11-25
00816777026019LVISMicrovention, Inc.NJE2018-11-25
00816777026026LVISMicrovention, Inc.NJE2018-11-25
00810170014420LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014437LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014451LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014468LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170016288LVISMicrovention, Inc.NJE2018-11-25
00810170016295LVISMicrovention, Inc.NJE2018-11-25
00810170016301LVISMicrovention, Inc.NJE2018-11-25
00810170016318LVISMicrovention, Inc.NJE2018-11-25
00810170016325LVISMicrovention, Inc.NJE2018-11-25
00810170016332LVISMicrovention, Inc.NJE2018-11-25
00810170016349LVISMicrovention, Inc.NJE2018-11-25
00810170018510LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018527LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018619LVISMicrovention, Inc.NJE2018-11-25
00810170018626LVISMicrovention, Inc.NJE2018-11-25
00810170018961LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018978LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018985LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018992LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170019005LVISMicrovention, Inc.NJE2018-11-25
00810170019012LVISMicrovention, Inc.NJE2018-11-25
00810170019029LVISMicrovention, Inc.NJE2018-11-25
00810170019036LVISMicrovention, Inc.NJE2018-11-25
00810170019043LVISMicrovention, Inc.NJE2018-11-25