Transseptal Introducer

Primary DI
00858769006296
Brand
Transseptal Introducer
Company
PPMDM
Model
TSIL0881
Catalog number
TSIL0881
Device description
8F x 81cm Transseptal Introducer Set L0 Curve
Published
2018-11-09
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181031000TSI Transseptal IntroducerPressure Products Medical Device Manufacturing, LLC2018-10-26DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30858769006297PackageGS15In Commercial Distribution
00858769006296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085876900629730858769006297
00858769006296008587690062968587690062960858769006296

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.

Regulatory Flags#

DUNS number
081047841
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858769006487SafeSept RF Transseptal GuidewireSSRF132SSRF1322026-03-23
00858769006500SafeSept RF Transseptal GuidewireSSRF2322026-03-23
00858769006524SafeSept RF Transseptal GuidewireSSRF1352026-03-23
00858769006531SafeSept RF Transseptal GuidewireSSRF135RSSRF135R2026-03-23
00858769006548SafeSept RF Transseptal GuidewireSSRF2352026-03-23
00858769006555SafeSept RF Transseptal GuidewireSSRF235R2026-03-23
30858769006488SafeSept RF Transseptal GuidewireSSRF132SSRF1322026-03-23
00858769006494SafeSept RF Transseptal GuidewireSSRF132RSSRF132R2026-03-23
30858769006501SafeSept RF Transseptal GuidewireSSRF2322026-03-23
00858769006517SafeSept RF Transseptal GuidewireSSRF232R2026-03-23
30858769006525SafeSept RF Transseptal GuidewireSSRF1352026-03-23
30858769006532SafeSept RF Transseptal GuidewireSSRF135RSSRF135R2026-03-23
30858769006549SafeSept RF Transseptal GuidewireSSRF2352026-03-23
30858769006556SafeSept RF Transseptal GuidewireSSRF235R2026-03-23
00858769006425SafeSharp Transseptal NeedleCLICK071CLICK0712024-07-02
00858769006449SafeSharp Transseptal NeedleCLICK098CLICK0982024-07-02
00858769006456SafeSharp Transseptal NeedleCLICK171CLICK1712024-07-02
00858769006470SafeSharp Transseptal NeedleCLICK198CLICK1982024-07-02
30858769006426SafeSharp Transseptal NeedleCLICK071CLICK0712024-07-02
30858769006440SafeSharp Transseptal NeedleCLICK098CLICK0982024-07-02

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