Turbo Tandem™ 482-110

GUDID M204482110AA0

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter

Spectranetics Corporation

Atherectomy laser system beam guide-catheter, peripheral

Primary Device ID	M204482110AA0
NIH Device Record Key	968f0475-10de-4d84-9775-a119b60bef92
Commercial Distribution Status	In Commercial Distribution
Brand Name	Turbo Tandem™
Version Model Number	482-110AA
Catalog Number	482-110
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	false
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

Device Dimensions

Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 Centimeter
Length	110 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813132020255 [Primary]
HIBCC	M204482110AA0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112032

FDA Product Code

MCW	Catheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

Ethylene Oxide

[M204482110AA0]

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

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M204482110AA0	Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
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