NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter R-410-152

GUDID NRP368

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

NORTH EAST SCIENTIFIC INC

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 IDNRP368
NIH Device Record Key12704b0e-81f8-46e8-89d5-8581ca968852
Commercial Distribution Discontinuation2023-07-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter
Version Model NumberR-410-152
Catalog NumberR-410-152
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
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com

Device Dimensions

Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Guidewire Compatibility4 French

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCNRP368 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-13
Device Publish Date2022-08-22

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

NRP368The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reprocessed
B227NRP3680R-410-152
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