Steerable Introducer Sheath 12F PN1008533-004

GUDID 00850004312049

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 dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use

• Primary Device ID: 00850004312049
• NIH Device Record Key: bf810016-32f3-4057-9d6f-229fd6fdab66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steerable Introducer Sheath 12F
• Version Model Number: SS120065
• Catalog Number: PN1008533-004
• Company DUNS: 790487263
• Company Name: FREUDENBERG MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com

Device Dimensions

• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 65 Centimeter
• Catheter Gauge: 12 French

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004312049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192422

FDA Product Code

• DRA: Catheter, Steerable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-21
• Device Publish Date: 2020-01-13

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