FDA.reportPublic FDA data

AccuStick™ II

Primary DI
08714729157588
Brand
AccuStick™ II
Company
BOSTON SCIENTIFIC CORPORATION
Model
M001207020
Device description
Introducer System
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGZACCESSORIES, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729157588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729157588087147291575888714729157588

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

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
true
HCT/P
false
Kit
true
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
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20653160392375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KGZ2026-02-26
06937440443811YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
06937440443828YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
40198459435202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
40704411017883AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
04048223118702FixoLongPajunk GmbH MedizintechnologieKGZ2025-04-04
05708932767811SopranoColoplast A/SKGZ2025-03-26
20192253053606DevonCardinal Health 200, LLCKGZ2025-03-25
20192253042020DevonCardinal Health 200, LLCKGZ2025-03-07
20192253042037DevonCardinal Health 200, LLCKGZ2025-03-07
00840306834936Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-11
00840306835155Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-11
00840306835124Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-10
00860012804405BladeClearPATHWAY MEDTECH, LLCKGZ2024-11-04
00860012804412BladeClearPATHWAY MEDTECH, LLCKGZ2024-11-04
00840306836039Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-23
10884521811546RitusCovidien LPKGZ2024-10-21
00840306835162Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835179Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835186Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835209Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835216Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835223Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835230Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835247Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
05708932767545Insertion ToolCOLOPLAST CORP.KGZ2024-09-27
50382904275650BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
50382904275612BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275629BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275636BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20