SLS™II 500-012

GUDID M2045000120

SLS™II Laser Sheath

Spectranetics Corporation

Pacing lead extraction kit, single-use
Primary Device IDM2045000120
NIH Device Record Key9f4cedd1-7011-4b1a-a6cb-2e098d9badb9
Commercial Distribution Discontinuation2019-02-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSLS™II
Version Model Number500-012
Catalog Number500-012
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
HIBCCM2045000120 [Primary]

FDA Product Code

MFADevice, Removal, Pacemaker Electrode, Percutaneous

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

Ethylene Oxide


[M2045000120]

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 [SLS™II]

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M204500001AA0SLS™II Laser Sheath
M2045000130SLS™II Laser Sheath
M2045000120SLS™II Laser Sheath
M2045000010SLS™II Laser Sheath

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