Chalgren

FDA UDI

Class II (US FDA UDI)

by Chalgren Enterprises, Inc.

Identity

Trade Name: Chalgren FDA UDI
Generic Name: Electromyographic needle electrode, single-use FDA UDI
Device Name: Detachable Monopolar Needle Electrode, EMG, 50mm x 26ga FDA UDI
Model / Reference: 110-650 FDA UDI
Description: Detachable Monopolar Needle Electrode, EMG, 50mm x 26ga FDA UDI

Identifiers

Catalog Number: 110-650 FDA UDI
Primary DI / UDI-DI: 00816020020030 FDA UDI
510(k) Number: K912283 FDA UDI
FDA Product Code: IKT FDA UDI
GMDN Term: Electromyographic needle electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 26 Gauge FDA UDI

Category: Electromyographic needle electrode, single-use

Chalgren by Chalgren Enterprises, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K912283 also covers:

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

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Manufacturer

Manufacturer: Chalgren Enterprises, Inc.

Sources (1)

FDA UDI 3feb4125-815e-4000-aad9-08383670305e 37 fields · synced Jun 8, 2026