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NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter

FDA UDI

Class II (US FDA UDI)

by Northeast Scientific, Inc.

Identity

Trade Name
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter FDA UDI
Generic Name
Atherectomy laser system beam guide-catheter, peripheral FDA UDI
Model / Reference
R-414-159 FDA UDI

Identifiers

Catalog Number
R-414-159 FDA UDI
Primary DI / UDI-DI
B227NRP1301 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
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

Category: Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter by Northeast Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Atherectomy laser system beam guide-catheter, peripheral.

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 0220357b-04a5-4bcf-9d18-d00ae2db3bd8 34 fields · synced May 31, 2026