Empire Microincision Needle Electrodes

Empire Elec. Sterile, 1.128" Curved Ndle

Registry build 21.09.26
2manufacturers in China registered for this device type
27catalogue numbers in this listing

Who Else Makes It

All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JOS
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26

Record

Regulatory record for Empire microIncision Needle Electrodes
Listed by Cynosure, LLC, United States
FDA product code JOS
Device type Electrode, Electrosurgical
Device class Class 2
Regulation 21 CFR 878.4400
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2016-09-21
Record revised 2023-01-11 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Empire microIncision Needle Electrodes
Catalogue number Size Per pack Status
TEE325 2 In distribution
TEE301 2 In distribution
TEE303 2 In distribution
QTEE327 2 In distribution
TEE319 2 In distribution
TEE314 2 In distribution
TEE306 2 In distribution
QTEE309 2 In distribution
QTEE301 2 In distribution
QTEE303 2 In distribution
TEE308 2 In distribution
TEE326 2 In distribution
QTEE308 2 In distribution
TEE311 2 In distribution
TEE317 2 In distribution
TEE316 2 In distribution
TEE305 2 In distribution
TEE307 2 In distribution
QTEE305 2 In distribution
TEE320 2 In distribution
TEE328 2 In distribution
QTEE312 2 In distribution
TEE302 2 In distribution
TEE312 2 In distribution
TEE327 2 In distribution
TEE318 2 In distribution
QTEE302 2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Assi Accurate Surgical & Scientific Instruments Corp. 55
Cameron-Miller Cameron-Miller, Inc. 34
Kirwan Kirwan Surgical Products, LLC. 30
Round Loop Electrode Cynosure, LLC 22
Oval Loop Electrode Cynosure, LLC 22
Needle Electrode Cynosure, LLC 15
Ball Electrode Cynosure, LLC 15
Electrode, Electrosurgical Richard Wolf Gmbh 14
Diamond Loop Electrode Cynosure, LLC 13
Triangle Loop Electrode Cynosure, LLC 11
Lletz Bayonet Cynosure, LLC 9
Vari-TIP Wire Electrode Cynosure, LLC 8

Showing 12 of 138. All products under Electrode, Electrosurgical

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer