Rochester

FDA UDI

Class II (US FDA UDI)

by Advantage Medical Electronics, LLC

Identity

Trade Name: Rochester FDA UDI
Generic Name: Electromyographic needle electrode, single-use FDA UDI
Device Name: DISPOSABLE CONCENTRIC NEEDLE ELECTRODE 27 GA, 25MM NEEDLE, YELLOW FDA UDI
Model / Reference: NC-852725 FDA UDI
Description: DISPOSABLE CONCENTRIC NEEDLE ELECTRODE 27 GA, 25MM NEEDLE, YELLOW FDA UDI

Identifiers

Primary DI / UDI-DI: 00849593025386 FDA UDI
FDA Product Code: GXZ FDA UDI
IKT FDA UDI
GMDN Term: Electromyographic needle electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 FDA UDI
890.1385 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Electromyographic needle electrode, single-use

Rochester by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromyographic needle electrode, single-use.

The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC. · Class II
Bio Protech — BIO PROTECH USA, INC. · Class II
MediMax Tech — MEDIMAX TECH INC. · Class II
Dragonfly® — NEUROVISION MEDICAL PRODUCTS, INC. · Class II
Cobra® — NEUROVISION MEDICAL PRODUCTS, INC. · Class II
Neuroline InojectNeurology Needle Electrodes — Ambu A/S · Class II
NATUS NEUROLOGY — Natus Neurology Incorporated · Class II
BIONEN — BIONEN SAS DI BARBARA NENCIONI & C. · 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Advantage Medical Electronics, LLC

Sources (1)

FDA UDI bcd816f0-d01c-4205-a835-de10aa5563d4 33 fields · synced May 30, 2026