NES Reprocessed .035 Stryker Catheter R-S88901

GUDID B227RS889011

NES Reprocessed .035 IVUS reprocessed for Stryker (SSS)

NORTH EAST SCIENTIFIC INC

Intravascular ultrasound imaging catheter, reprocessed
Primary Device IDB227RS889011
NIH Device Record Key7e9cdfe4-4e49-4d99-bcf9-990029234942
Commercial Distribution Discontinuation2030-11-24
Commercial Distribution StatusIn Commercial Distribution
Brand NameNES Reprocessed .035 Stryker Catheter
Version Model NumberR-S88901
Catalog NumberR-S88901
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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB227RS889011 [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 Date2024-08-26
Device Publish Date2024-08-16

Devices Manufactured by NORTH EAST SCIENTIFIC INC

B227RS889011 - NES Reprocessed .035 Stryker Catheter2024-08-26NES Reprocessed .035 IVUS reprocessed for Stryker (SSS)
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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