Novo Surgical Inc.

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical Inc. FDA UDI
Generic Name: Catheter-tip transducer, pressure FDA UDI
Device Name: fiber optic cable, for storz-compatible & male acmi_x000D__x000D_Caution: _x000D__x000D_To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes/Bipolar Forceps._x000D__x000D_For all monopolar electrodes/Bipolar Forceps, the useful life of this product is = 50 cycles and = 2 years._x000D__x000D_Please read complete Intructions for Use prior to use. FDA UDI
Model / Reference: E0130-10 FDA UDI
Description: fiber optic cable, for storz-compatible & male acmi_x000D__x000D_Caution: _x000D__x000D_To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes/Bipolar Forceps._x000D__x000D_For all monopolar electrodes/Bipolar Forceps, the useful life of this product is = 50 cycles and = 2 years._x000D__x000D_Please read complete Intructions for Use prior to use. FDA UDI

Identifiers

Catalog Number: E0130-10 FDA UDI
Primary DI / UDI-DI: 00842331141454 FDA UDI
FDA Product Code: EQH FDA UDI
GMDN Term: Catheter-tip transducer, pressure FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Catheter-tip transducer, pressure

Novo Surgical Inc. by Novo Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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OptoWire — Opsens · Class II
PrimeWire Prestige Pressure Guide Wire 185cm JTIP — Volcarica S.R.L. · Class II
PressureWire™ — LIGHTLAB IMAGING, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Novo Surgical, Inc.

Sources (1)

FDA UDI c625695f-318e-46c1-a113-46607bcab87b 35 fields · synced May 30, 2026