SightRail™ 555-510

GUDID M2045555100

SightRail™ Manual Dilator Sheath

Spectranetics Corporation

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: M2045555100
• NIH Device Record Key: dafeeaf1-b4cc-44aa-8221-75779eed77f1
• Commercial Distribution Discontinuation: 2019-02-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SightRail™
• Version Model Number: 555-510
• Catalog Number: 555-510
• Company DUNS: 151047370
• Company Name: Spectranetics Corporation
• 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: true
• 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: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com

Device Dimensions

• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch
• Lumen/Inner Diameter: 0.127 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M2045555100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133631

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

Sterilization

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

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

[M2045555100]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-10-26
• Device Publish Date: 2014-08-26

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• M204555508AA0: SightRail™ Manual Dilator Sheath
• M204550013AA0: SightRail™ Manual Dilator Sheath
• M204550011AA0: SightRail™ Manual Dilator Sheath
• M204550010AA0: SightRail™ Manual Dilator Sheath
• M204550008AA0: SightRail™ Manual Dilator Sheath
• M2045555130: SightRail™ Manual Dilator Sheath
• M2045555110: SightRail™ Manual Dilator Sheath
• M2045555100: SightRail™ Manual Dilator Sheath
• M2045555080: SightRail™ Manual Dilator Sheath
• M2045500130: SightRail™ Manual Dilator Sheath
• M2045500110: SightRail™ Manual Dilator Sheath
• M2045500100: SightRail™ Manual Dilator Sheath
• M2045500080: SightRail™ Manual Dilator Sheath