Home GUDID 00850004312025 Steerable Introducer Sheath 8.5F Medium Curl
Primary DI 00850004312025
Brand Steerable Introducer Sheath 8.5F Medium Curl
Company FREUDENBERG MEDICAL, LLC
Model SS085075M
Catalog number PN1008533-002
Device description The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.
Published 2019-10-25
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 00850004312025 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 00850004312025 00850004312025 850004312025 0850004312025
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 0 Catheter Working Length 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Regulatory Flags# DUNS number 790487263 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 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 DI Brand Model Catalog Published 00813307011552 InHealth Technologies; Blom-Singer BE 6050 2017-01-01 00813307011569 InHealth Technologies; Blom-Singer BE 2050 2017-01-01 00813307013099 InHealth Technologies; Blom-Singer BE 6036 2017-01-01 00813307013105 InHealth Technologies; Blom-Singer BE 2036 2017-01-01 00813307013174 InHealth Technologies; Blom-Singer BE 2051 2017-01-01 00813307013181 InHealth Technologies; Blom-Singer BE 2052 2017-01-01 00198715836998 EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING 668782-101 PN1007960-100 2026-01-29 00850004312001 EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING 668782-100 PN1007960-100 2021-06-15 00850004312049 Steerable Introducer Sheath 12F SS120065 PN1008533-004 2020-01-13 00850004312018 Steerable Introducer Sheath 8.5F Small Curl SS085075S PN1008533-001 2019-10-25 00850004312032 Steerable Introducer Sheath 8.5F Large Curl SS085075L PN1008533-003 2019-10-25 00848253003634 InHealth Technologies; Blom-Singer PK 2106 2019-07-10 00848253003641 InHealth Technologies; Blom-Singer PK 2107 2019-07-10 00848253003399 InHealth Technologies; Blom-Singer PK 2100 2019-06-07 00848253003405 InHealth Technologies; Blom-Singer PK 2101 2019-06-07 00848253003412 InHealth Technologies; Blom-Singer PK 2102 2019-06-07 00848253003429 InHealth Technologies; Blom-Singer PK 2103 2019-06-07 00848253003436 InHealth Technologies; Blom-Singer PK 2104 2019-06-07 00848253003443 InHealth Technologies; Blom-Singer PK 2105 2019-06-07 00813307012597 InHealth Technologies; Blom-Singer BE 6045 2018-01-01
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