2D Helical - 35

Primary DI
08714729158851
Brand
2D Helical - 35
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0013727040
Catalog number
M0013727040
Device description
Fibered Platinum Coil
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729158851PackageGS15In Commercial Distribution
08714729195597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729158851087147291588518714729158851
08714729195597087147291955978714729195597

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169724217Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724224Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724231Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724248Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724255Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724262Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724279Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724286Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
10886704076957DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076971DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076988DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077022DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077039DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077046DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077077DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077176DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077183DELTAFILLCerenovus, Inc.KRD2016-11-16