NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter R-410-154

GUDID 00850044399062

The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES)

NORTH EAST SCIENTIFIC INC

Atherectomy laser system beam guide-catheter, peripheral
Primary Device ID00850044399062
NIH Device Record Key71f401da-15ba-4dca-a56b-91e81d3a7786
Commercial Distribution StatusIn Commercial Distribution
Brand NameNES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter
Version Model NumberR-410-154
Catalog NumberR-410-154
Company DUNS608625823
Company NameNORTH EAST SCIENTIFIC INC
Device Count1
DM Exempttrue
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

Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com
Phone203-756-2111
Emailsales@nescientific.com

Device Dimensions

Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Introducer Sheath Compatibilit4 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100850044399062 [Primary]
HIBCCB227NRP1300 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QTFReprocessed Atherectomy Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-29
Device Publish Date2025-05-21

On-Brand Devices [NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter]

NRP130The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed b
B227NRP1300The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed b
00850044399062The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed b

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