Steerable Introducer Sheath 8.5F Medium Curl PN1008533-002

GUDID 00850004312025

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.

FREUDENBERG MEDICAL, LLC

Vascular guide-catheter, single-use
Primary Device ID00850004312025
NIH Device Record Keyfc3be494-8877-412b-a085-48389f5ec8bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteerable Introducer Sheath 8.5F Medium Curl
Version Model NumberSS085075M
Catalog NumberPN1008533-002
Company DUNS790487263
Company NameFREUDENBERG MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com

Device Dimensions

Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French
Catheter Working Length75 Centimeter
Catheter Gauge8.5 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004312025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-04
Device Publish Date2019-10-25

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