What is FDA product code ODR?

Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

General & Plastic Surgery › SurgicalElectrosurgical Patient Return Electrode

Extra-Large Grounding PAD, 25 PCS

Name: Extra-Large Grounding PAD, 25 PCS
Brand: Extra-Large Grounding PAD, 25 PCS

Catalogue number MEL-01221, listed by Cynosure, LLC, United States, under Electrosurgical Patient Return Electrode. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

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

Chinese manufacturers registered for FDA product code ODR
Manufacturer	City	Province	Registered as	Device types
Zhejiang Shuyou Surgical Instrument Co., Ltd.	Huzhou	Zhejiang	Contract manufacturer	13
Top-rank Health Care Co., Ltd.	Shaoxing	Zhejiang	Contract manufacturer	7

Record

Regulatory record for Extra-Large Grounding PAD, 25 PCS
Listed by	Cynosure, LLC, United States
FDA product code	ODR
Device type	Electrosurgical Patient Return Electrode
Device class	Class 2
Regulation	21 CFR 878.4400
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K190678
Record published	2020-01-31
Record revised	2023-01-11 (version 2)

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 Extra-Large Grounding PAD, 25 PCS
Catalogue number	Size	Per pack	Status
MEL-01221		25	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Patient Dispersive Pad	Gynex Corporation	2
Neutral PAD	Cynosure, LLC	2
Cameron-Miller	Cameron-Miller, Inc.	1
Assi	Accurate Surgical & Scientific Instruments Corp.	1
Patient Dispercive Pad	Gynex Corporation	1
IEC Neutral PAD	Cynosure, LLC	1
IEC Neutral Plate	Cynosure, LLC	1
Extra-Large Grounding PAD	Cynosure, LLC	1

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.