GlideLight™ 500-302

GUDID M2045003020

GlideLight™ Laser Sheath

Spectranetics Corporation

Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use Pacing lead extraction kit, single-use
Primary Device IDM2045003020
NIH Device Record Key0bf80970-2fb9-43e1-8915-3320957c2a82
Commercial Distribution Discontinuation2019-02-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGlideLight™
Version Model Number500-302
Catalog Number500-302
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 Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 Inch
Outer Diameter0.192 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
HIBCCM2045003020 [Primary]

FDA Product Code

MFADevice, Removal, Pacemaker Electrode, Percutaneous

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

Ethylene Oxide


[M2045003020]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.