NORTH EAST SCIENTIFIC INC

Address:2142 Thomaston Ave,Waterbury,CT,06704,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (NUJ) (4) Reprocessed Intravascular Ultrasound Catheter (OWQ) (2) Tray, Surgical (LRP) (2) Catheter, Ultrasound, Intravascular (OBJ) (1) Reprocessed Atherectomy Catheter (QTF) (1) Retractor (GAD) (1)

Premarket Exempt

No Yes

Clear

EsoSure - B2271000010 Catalog Number : 100001

Device Description : The EsoSure Esophageal Retractor is intended to move the esophagus.

Device Class : 1

Duns Number: 608625823

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Vein Ablation Pack - B227700004 Catalog Number : 700004

Device Description : Vein ablation pack. Stradis Part # 682-2129. 5 Packs per case.

Device Class : 1

Duns Number: 608625823

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Vein Ablation Pack - B227700005 Catalog Number : 700005

Device Description : Vein ablation pack. Stradis Part # 682-2187. 1 pack per case.

Device Class : 1

Duns Number: 608625823

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

NES Reprocessed Varicose Vein RF Catheter - B227RCF73600 Catalog Number : R-CF7-3-60

Device Description : The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-3-60) is The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-3-60) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Device Class : 2

Duns Number: 608625823

Premarket Exempt : Yes

Product Code : NUJ

Prescription Use : Yes

Device Count : 1

NES Reprocessed Varicose Vein RF Catheter - B227RCF771000 Catalog Number : R-CF7-7-100

Device Description : The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-100) i The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-100) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Device Class : 2

Duns Number: 608625823

Premarket Exempt : Yes

Product Code : NUJ

Prescription Use : Yes

Device Count : 1

NES Reprocessed Varicose Vein RF Catheter - B227RCF77600 Catalog Number : R-CF7-7-60

Device Description : The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-60) is The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-60) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Device Class : 2

Duns Number: 608625823

Premarket Exempt : Yes

Product Code : NUJ

Prescription Use : Yes

Device Count : 1

NES Reprocessed RF Stylet (RFS) - B227RRFS2612 Catalog Number : R-RFS2-6-12

Device Description : The device is the Covidien ClosureRFS Endovenous Radiofrequency (RF) Stylet that The device is the Covidien ClosureRFS Endovenous Radiofrequency (RF) Stylet that is reprocessed by Northeast Scientific, Inc.

Device Class : 2

Duns Number: 608625823

Premarket Exempt : No

Product Code : NUJ

Prescription Use : Yes

Device Count : 1

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter - NRP014 Catalog Number : R-014R

Device Description : The device is the Philips Vision PV .014P RX Digital IVUS catheter that is repro The device is the Philips Vision PV .014P RX Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).

Device Class : 2

Duns Number: 608625823

Premarket Exempt : No

Product Code : OBJ, OWQ

Prescription Use : Yes

Device Count : 1

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter - NRP368 Catalog Number : R-410-152

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

Device Class : 2

Duns Number: 608625823

Premarket Exempt : No

Product Code : QTF

Prescription Use : Yes

Device Count : 1

NES Reprocessed Visions PV .035 Digital IVUS Catheter - R88901 Catalog Number : R-88901

Device Description : The device is the Philips Vision PV .035 Digital IVUS catheter that is reprocess The device is the Philips Vision PV .035 Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).

Device Class : 2

Duns Number: 608625823

Premarket Exempt : No

Product Code : OWQ

Prescription Use : Yes

Device Count : 1

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