SightRail™

Basic Information

• Brand Name: SightRail™
• Primary DI: M2045555130
• Version / Model: 555-513
• Catalog Number: 555-513
• Company Name: Spectranetics Corporation
• Labeler DUNS: 151047370
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-26
• Public Version: 5
• Public Version Date: 2021-10-26
• Public Version Status: Update
• Public Device Record Key: 8aac7d4f-17a3-44ad-b72d-f4c2681e72ce
• Distribution End Date: 2019-02-06

Device Description

SightRail™ Manual Dilator Sheath

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: No
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	870.1310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38128	Vascular dilator, single-use	A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M2045555130	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K133631	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	0.167	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 140 Degrees Fahrenheit