VisiSheath™ 501-214

GUDID M2045012140

VisiSheath™ Dilator Sheath

Spectranetics Corporation

Vascular dilator, single-use

• Primary Device ID: M2045012140
• NIH Device Record Key: 05ca9249-6ad9-447a-bdd4-e904650b3cee
• Commercial Distribution Discontinuation: 2019-02-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VisiSheath™
• Version Model Number: 501-214
• Catalog Number: 501-214
• 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: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com
• Phone: 1-800-633-0967
• Email: complaints@spnc.com

Device Dimensions

• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter

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	M2045012140 [Primary]

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

Sterilization

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

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

Ethylene Oxide

[M2045012140]

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: 2014-08-19

On-Brand Devices [VisiSheath™]

• M204501216AA0: VisiSheath™ Dilator Sheath
• M204501214AA0: VisiSheath™ Dilator Sheath
• M204501212AA0: VisiSheath™ Dilator Sheath
• M204501116AA0: VisiSheath™ Dilator Sheath
• M204501114AA0: VisiSheath™ Dilator Sheath
• M204501112AA0: VisiSheath™ Dilator Sheath
• M204501016AA0: VisiSheath™ Dilator Sheath
• M204501014AA0: VisiSheath™ Dilator Sheath
• M204501012AA0: VisiSheath™ Dilator Sheath
• M2045012160: VisiSheath™ Dilator Sheath
• M2045012140: VisiSheath™ Dilator Sheath
• M2045012120: VisiSheath™ Dilator Sheath
• M2045011160: VisiSheath™ Dilator Sheath
• M2045011140: VisiSheath™ Dilator Sheath
• M2045011120: VisiSheath™ Dilator Sheath
• M2045010160: VisiSheath™ Dilator Sheath
• M2045010140: VisiSheath™ Dilator Sheath
• M2045010120: VisiSheath™ Dilator Sheath