FDA.reportPublic FDA data

AccuStick™ Needle

Primary DI
08714729862932
Brand
AccuStick™ Needle
Company
BOSTON SCIENTIFIC CORPORATION
Model
H7493937021200
Device description
Introducer Needle
Published
2016-08-17
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

Product Codes#

Code, Name table
CodeName
GCBNEEDLE, CATHETER

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729862918PackageGS110In Commercial Distribution
08714729862932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729862918087147298629188714729862918
08714729862932087147298629328714729862932

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of 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

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526625008ACUITY™706070602026-10-15
08714729748861RX Cholangiogram KitM005711502016-09-24
08714729748878RX Cholangiogram KitM005711602016-09-24
08714729749097RX Cholangiogram KitM005714002016-09-24
08714729749110RX Cholangiogram KitM005714202016-09-24
08714729749257RX Cholangiogram KitM005715602016-09-24
08714729749295RX Cholangiogram KitM005716002016-09-24
08714729749332RX Cholangiogram KitM005716402016-09-24
08714729749394RX Cholangiogram KitM005717002016-09-24
08714729749509RX Cholangiogram KitM005718102016-09-24
08714729749615RX Cholangiogram KitM005719202016-09-24
00191506065577Ranger™H74939501400470H749395014004702026-10-14
00191506065584Ranger™H74939501400670H749395014006702026-10-14
00191506065591Ranger™H74939501400870H749395014008702026-10-14
00191506065607Ranger™H74939501401070H749395014010702026-10-14
00191506065614Ranger™H74939501401270H749395014012702026-10-14
00191506065621Ranger™H74939501401570H749395014015702026-10-14
00191506065638Ranger™H74939501402070H749395014020702026-10-14
00191506065645Ranger™H74939501400410H749395014004102026-10-14
00191506065652Ranger™H74939501400610H749395014006102026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450452974MAK-NV™Merit Medical Systems, Inc.GCB2026-09-29
00884450453339MAK-NV™Merit Medical Systems, Inc.GCB2026-09-29
10810068811084MONARCH™ Kit Catheter & AccessoriesAuris Health, Inc.GCB2026-05-05
10810068811060MONARCH™Guided Percutaneous Access KitAuris Health, Inc.GCB2026-05-04
00884450820667MAK-NV™Merit Medical Systems, Inc.GCB2026-02-24
00661392008960LSL HEALTHCARELSL Industries, LLCGCB2025-10-30
10841156111830TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111847TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111854TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111861TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111837TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111844TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111851TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111868TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
14026704920263PILLINGTELEFLEX INCORPORATEDGCB2024-07-15
14026704920270PILLINGTELEFLEX INCORPORATEDGCB2024-07-15
00884450820643MAK-NV™Merit Medical Systems, Inc.GCB2024-06-28
10884450820640MAK-NV™Merit Medical Systems, Inc.GCB2024-06-28
00884450820568MAK-NV™Merit Medical Systems, Inc.GCB2024-06-18
10884450820565MAK-NV™Merit Medical Systems, Inc.GCB2024-06-18
00884450820612MAK-NV™Merit Medical Systems, Inc.GCB2024-06-15
10884450820619MAK-NV™Merit Medical Systems, Inc.GCB2024-06-15
00884450820636MAK-NV™Merit Medical Systems, Inc.GCB2024-06-12
10884450820633MAK-NV™Merit Medical Systems, Inc.GCB2024-06-12
10381780538493MicroFrance®INTEGRA MICROFRANCEGCB2024-05-29
10841156110949TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110956TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110963TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110970TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110946TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08