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Extra-Large Grounding Pad, 25 Pcs

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name
EXTRA-LARGE GROUNDING PAD, 25 PCS FDA UDI
Generic Name
Electrosurgical return electrode, single-use, sterile FDA UDI
Device Name
EXTRA-LARGE GROUNDING PAD, 25 PCS FDA UDI
Model / Reference
MEL-01221 FDA UDI
Description
EXTRA-LARGE GROUNDING PAD, 25 PCS FDA UDI

Identifiers

Primary DI / UDI-DI
10841494108431 FDA UDI
510(k) Number
K190678 FDA UDI
FDA Product Code
ODR FDA UDI
GMDN Term
Electrosurgical return electrode, single-use, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical return electrode, single-use, sterile

Extra-Large Grounding Pad, 25 Pcs by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical return electrode, single-use, sterile.

Cleared under the same submission

K190678 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cynosure, LLC

Sources (1)

  • FDA UDI 0e854408-e1a4-4d96-800c-1a4ea6c53bad 34 fields · synced May 31, 2026