VisiSheath™ 501-016

GUDID M204501016AA0

VisiSheath™ Dilator Sheath

Spectranetics Corporation

Vascular dilator, single-use
Primary Device IDM204501016AA0
NIH Device Record Keyf5b4c6cd-dad3-4c30-a97f-9a2719984da7
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisiSheath™
Version Model Number501-016AA
Catalog Number501-016
Company DUNS151047370
Company NameSpectranetics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com

Device Dimensions

Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter
Lumen/Inner Diameter5.9 Millimeter
Length43 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100813132020378 [Primary]
HIBCCM204501016AA0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DREDilator, Vessel, For Percutaneous Catheterization

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


[M204501016AA0]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-02-06

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Trademark Results [VisiSheath]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VISISHEATH
VISISHEATH
77589213 3768583 Live/Registered
The Spectranetics Corporation
2008-10-09

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