Home GUDID 30858769006334 Transseptal Introducer
Primary DI 30858769006334
Brand Transseptal Introducer
Company PPMDM
Model TSIL08581
Catalog number TSIL08581
Device description 8.5F 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
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DYB Introducer, Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYB Introducer, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30858769006334 Package GS1 5 In Commercial Distribution 00858769006333 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30858769006334 30858769006334 00858769006333 00858769006333 858769006333 0858769006333
GMDN Terms# Term, Definition table Term Definition Vascular catheter introduction set, nonimplantable A 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.
Regulatory Flags# DUNS number 081047841 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 true 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 DI Brand Model Catalog Published 00858769006487 SafeSept RF Transseptal Guidewire SSRF132 SSRF132 2026-03-23 00858769006500 SafeSept RF Transseptal Guidewire SSRF232 2026-03-23 00858769006524 SafeSept RF Transseptal Guidewire SSRF135 2026-03-23 00858769006531 SafeSept RF Transseptal Guidewire SSRF135R SSRF135R 2026-03-23 00858769006548 SafeSept RF Transseptal Guidewire SSRF235 2026-03-23 00858769006555 SafeSept RF Transseptal Guidewire SSRF235R 2026-03-23 30858769006488 SafeSept RF Transseptal Guidewire SSRF132 SSRF132 2026-03-23 00858769006494 SafeSept RF Transseptal Guidewire SSRF132R SSRF132R 2026-03-23 30858769006501 SafeSept RF Transseptal Guidewire SSRF232 2026-03-23 00858769006517 SafeSept RF Transseptal Guidewire SSRF232R 2026-03-23 30858769006525 SafeSept RF Transseptal Guidewire SSRF135 2026-03-23 30858769006532 SafeSept RF Transseptal Guidewire SSRF135R SSRF135R 2026-03-23 30858769006549 SafeSept RF Transseptal Guidewire SSRF235 2026-03-23 30858769006556 SafeSept RF Transseptal Guidewire SSRF235R 2026-03-23 00858769006425 SafeSharp Transseptal Needle CLICK071 CLICK071 2024-07-02 00858769006449 SafeSharp Transseptal Needle CLICK098 CLICK098 2024-07-02 00858769006456 SafeSharp Transseptal Needle CLICK171 CLICK171 2024-07-02 00858769006470 SafeSharp Transseptal Needle CLICK198 CLICK198 2024-07-02 30858769006426 SafeSharp Transseptal Needle CLICK071 CLICK071 2024-07-02 30858769006440 SafeSharp Transseptal Needle CLICK098 CLICK098 2024-07-02
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