Device
Disposable Grounding Pad, Dual Element, with 9ft Cord
Manufacturer
NEW DEANTRONICS TAIWAN LTD.
NEW DEANTRONICS TAIWAN LTD.
Model: EP211
DI: 00813527027005
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Disposable Grounding Pad, Dual Element, with 9ft Cord
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d83cf6e5-fddb-444e-ae41-76936697a468
Distribution Status:
In Commercial Distribution
DUNS Number:
656388953
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00813527027005
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58494
Name: Electrosurgical return electrode, single-use
Definition:
A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.
FDA Product Codes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Keep Dry