SYPHONTRAK SDA

Basic Information

• Brand Name: SYPHONTRAK SDA
• Primary DI: 00816900020259
• Version / Model: GEN-10820-115
• Catalog Number: GEN-10820-115
• Company Name: Inneuroco, Inc.
• Labeler DUNS: 080407341
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-08
• Public Version: 7
• Public Version Date: 2023-03-03
• Public Version Status: Update
• Public Device Record Key: aeb103d3-233b-4aa1-b1d9-e6153d7ba365
• Distribution End Date: 2017-12-29

Device Description

Catheter, Hemostasis Valve, & Introducer

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQY	Catheter, Percutaneous	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17846	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 (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816900020259	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	115	Centimeter
Lumen/Inner Diameter	.062	Inch
Outer Diameter	.083	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry, dark place.