FDA.reportPublic FDA data

Complex Helical - 18

Primary DI
08714729156055
Brand
Complex Helical - 18
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0013120440
Catalog number
M0013120440
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
08714729156055PackageGS15In Commercial Distribution
08714729195580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729156055087147291560558714729156055
08714729195580087147291955808714729195580

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
08714729390275Maverick™ XLH74937909401502016-09-24
08714729390282Maverick™ XLH74937909402002016-09-24
08714729390299Maverick™ XLH74937909451502016-09-24
08714729390305Maverick™ XLH74937909452002016-09-24
08714729390312Maverick™ XLH74937909501502016-09-24
08714729390329Maverick™ XLH74937909502002016-09-24
08714729390336Maverick™ XLH74937909551502016-09-24
08714729390343Maverick™ XLH74937909552002016-09-24
08714729390350Maverick™ XLH74937909601502016-09-24
08714729390367Maverick™ XLH74937909602002016-09-24
08714729739258NAM0014416602016-09-24
08714729860488WATCHMAN FLX™M635WU50200M635WU502002020-07-28
08714729860495WATCHMAN FLX™M635WU50240M635WU502402020-07-28
08714729860501WATCHMAN FLX™M635WU50270M635WU502702020-07-28
08714729860518WATCHMAN FLX™M635WU50310M635WU503102020-07-28
08714729860525WATCHMAN FLX™M635WU50350M635WU503502020-07-28
08714729848851Vessix™H749RDNDCR145002016-09-24
08714729848868Vessix™H749RDNDCL145002016-09-24
00802526628900LATITUDE™ Programming System330033002026-05-14
08714729224419Maverick®H74920620153702016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10857798005093Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005109Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005123Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005130Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005147Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10841156105655GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
10841156105662GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
10841156105679GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
07613327578577Target TetraStryker CorporationKRD2022-12-19
07613327578591Target TetraStryker CorporationKRD2022-12-19
07613327578607Target TetraStryker CorporationKRD2022-12-19
07613327578638Target TetraStryker CorporationKRD2022-12-19
07613327578676Target TetraStryker CorporationKRD2022-12-19
07613327578683Target TetraStryker CorporationKRD2022-12-19
07613327578690Target TetraStryker CorporationKRD2022-12-19
07613327578706Target TetraStryker CorporationKRD2022-12-19
07613327578737Target TetraStryker CorporationKRD2022-12-19
07613327578744Target TetraStryker CorporationKRD2022-12-19
07613327580099Target TetraStryker CorporationKRD2022-12-19
10841156106591GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
10841156106614GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
10841156106621GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
10841156106638GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
07613327466386TARGETStryker CorporationKRD2019-09-05
07613327466416TARGETStryker CorporationKRD2019-09-05
07613327466423TARGETStryker CorporationKRD2019-09-05
10841156100001OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27
10841156100018OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27
10841156100025OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27
10841156100032OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27