NES Reprocessed Visions PV .035 Digital IVUS Catheter R-88901

GUDID B227R889010

NORTH EAST SCIENTIFIC INC

Intravascular ultrasound imaging catheter, reprocessed
Primary Device IDB227R889010
NIH Device Record Keyf29a8418-28fe-45c0-9661-9fbc1e7330d4
Commercial Distribution Discontinuation2030-11-24
Commercial Distribution StatusIn Commercial Distribution
Brand NameNES Reprocessed Visions PV .035 Digital IVUS Catheter
Version Model NumberR-88901
Catalog NumberR-88901
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
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com
Phone203-756-2111
Emailmatt@smarthealth-care.com

Device Dimensions

Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch
Catheter Working Length90 Centimeter
Lumen/Inner Diameter0.035 Inch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB227R889010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWQReprocessed Intravascular Ultrasound Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-20
Device Publish Date2023-07-12

Devices Manufactured by NORTH EAST SCIENTIFIC INC

B227RS889011 - NES Reprocessed .035 Stryker Catheter2024-08-26 NES Reprocessed .035 IVUS reprocessed for Stryker (SSS)
B227R85900PST1 - NES Reprocessed Eagle Eye Platinum Short Tip Stryker2024-08-23 NES Reprocessed Eagle Eye Platinum Short Tip Catheter reprocessed for Stryker (SSS)
B227RS014R1 - NES Reprocessed .014 Stryker Catheter2024-08-23 NES Reprocessed .014 IVUS Catheter manufactured for Stryker (SSS)
B227RS85900P1 - NES Reprocessed Eagle Eye Platinum Long Tip Stryker2024-08-23 NES Reprocessed Eagle Eye Platinum Long Tip Catheter manufactured for Stryker (SSS)
B227NRP1301 - NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter2023-09-25
B227NRP1302 - NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter2023-09-25
B227NRP1303 - NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter2023-09-25
B227NRP3681 - NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter2023-09-25
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