Turbo-Power 423-050

GUDID 00813132029951

Turbo-Power Laser Atherectomy Catheter, 2.3mm

Spectranetics Corporation

Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral
Primary Device ID00813132029951
NIH Device Record Key3b602fd5-c648-460a-993f-c5b7a71e0b1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTurbo-Power
Version Model Number423-050AC
Catalog Number423-050
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 Kitfalse
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
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com

Device Dimensions

Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter
Outer Diameter2.3 Millimeter
Lumen/Inner Diameter0.018 Inch
Length125 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100813132029951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCWCatheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-20
Device Publish Date2023-12-12

On-Brand Devices [Turbo-Power]

00813132029951Turbo-Power Laser Atherectomy Catheter, 2.3mm
00813132029944Turbo-Power Laser Atherectomy Catheter, 2.0mm

Trademark Results [Turbo-Power]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TURBO-POWER
TURBO-POWER
86701531 4966361 Live/Registered
The Spectranetics Corporation
2015-07-22
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