GlideLight™ 500-301

GUDID M2045003010

GlideLight™ Laser Sheath

Spectranetics Corporation

Pacing lead extraction kit, single-use
Primary Device IDM2045003010
NIH Device Record Key91158d29-edf6-446a-9adc-f2510444e6b8
Commercial Distribution Discontinuation2019-02-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGlideLight™
Version Model Number500-301
Catalog Number500-301
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

Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com

Device Dimensions

Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch
Outer Diameter0.164 Inch

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
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
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
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM2045003010 [Primary]

FDA Product Code

MFADevice, Removal, Pacemaker Electrode, Percutaneous

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


[M2045003010]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-10-26
Device Publish Date2014-08-19

On-Brand Devices [GlideLight™]

M204500303AA0GlideLight™ Laser Sheath
M204500302AA0GlideLight™ Laser Sheath
M204500301AA0GlideLight™ Laser Sheath
M2045003030GlideLight™ Laser Sheath
M2045003020GlideLight™ Laser Sheath
M2045003010GlideLight™ Laser Sheath

Trademark Results [GlideLight]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GLIDELIGHT
GLIDELIGHT
85433970 4243271 Live/Registered
The Spectranetics Corporation
2011-09-28

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