FDA.reportPublic FDA data

VSI

Primary DI
10841156105921
Brand
VSI
Company
TELEFLEX INCORPORATED
Model
IPN001752
Catalog number
7962
Device description
VSI StraitSet micro-introducer kit
Published
2020-02-06
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841156105928PackageGS110In Commercial Distribution
10841156105921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084115610592820841156105928
1084115610592110841156105921

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
Catheter Gauge6French
Length15Centimeter

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16
14026704302366RUSCHIPN0505271807053002016-09-16
14026704302977RUSCHIPN0505911834052002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-18
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
10884450708955Prelude®Merit Medical Systems, Inc.DRE2026-07-18
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23
10884450706708Prelude®Merit Medical Systems, Inc.DRE2026-06-03
10884450415358Prelude®Merit Medical Systems, Inc.DRE2026-05-28
00685447020264VersaCross Connect™ Transseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020271VersaCross Connect™ Transseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020288VersaCross™ Large Access Trasseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020295VersaCross™ Large Access Trasseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
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04251244502089Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502096Catapult Guide SheathContract Medical International GmbHDRE2023-09-01