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NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter

FDA UDI

Class II (US FDA UDI)

by Northeast Scientific, Inc.

Identity

Trade Name
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter FDA UDI
Generic Name
Atherectomy laser system beam guide-catheter, peripheral FDA UDI
Device Name
The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES). FDA UDI
Model / Reference
R-410-154 FDA UDI
Description
The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES). FDA UDI

Identifiers

Primary DI / UDI-DI
NRP130 FDA UDI
FDA Product Code
QTF FDA UDI
GMDN Term
Atherectomy laser system beam guide-catheter, peripheral FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4875 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Working Length — 150 Centimeter FDA UDI
Lumen/Inner Diameter — .014 Inch FDA UDI
Guidewire Compatibility — 4 French FDA UDI

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter by Northeast Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Northeast Scientific, Inc.

Sources (1)

  • FDA UDI 3e50c36a-2d97-4f89-98a3-ed5d6d6209cc 36 fields · synced May 30, 2026