SLS™II 500-013

GUDID M204500013AA0

SLS™II Laser Sheath

Spectranetics Corporation

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• Primary Device ID: M204500013AA0
• NIH Device Record Key: 1cd507d9-f32a-465a-982e-3c1289e3bf5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SLS™II
• Version Model Number: 500-013AA
• Catalog Number: 500-013
• 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: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com

Device Dimensions

• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter
• Outer Diameter: 0.225 Inch
• Length: 50 Centimeter

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
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813132020316 [Primary]
HIBCC	M204500013AA0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960042

FDA Product Code

• MFA: Device, Removal, Pacemaker Electrode, Percutaneous

Sterilization

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

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

[M204500013AA0]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-02-06

On-Brand Devices [SLS™II]

• M204500013AA0: SLS™II Laser Sheath
• M204500012AA0: SLS™II Laser Sheath
• M204500001AA0: SLS™II Laser Sheath
• M2045000130: SLS™II Laser Sheath
• M2045000120: SLS™II Laser Sheath
• M2045000010: SLS™II Laser Sheath