← Back to catalogue

L’disq®

FDA UDI

Class II (US FDA UDI)

by CG MedTech Co., Ltd.

Identity

Trade Name
L’DISQ® FDA UDI
Generic Name
Electrosurgical return electrode, single-use, sterile FDA UDI
Model / Reference
PD01 FDA UDI

Identifiers

Primary DI / UDI-DI
08800015900010 FDA UDI
510(k) Number
K132797 FDA UDI
FDA Product Code
GEI 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrosurgical return electrode, single-use, sterile

L’disq® by CG MedTech Co., Ltd. — 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

K132797 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
CG MedTech Co., Ltd.

Sources (1)

  • FDA UDI 04b5b058-3348-44aa-a532-398dbf4d2bf6 34 fields · synced May 30, 2026