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Compass International

FDA UDI

Class II (US FDA UDI)

by Compass International

Identity

Trade Name
Compass International FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Device Name
Kelly Coagulation Probe FDA UDI
Model / Reference
KCP-20 FDA UDI
Description
Kelly Coagulation Probe FDA UDI

Identifiers

Catalog Number
KCP-20 FDA UDI
Primary DI / UDI-DI
B169KCP200 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

Compass International by Compass International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compass International

Sources (1)

  • FDA UDI 87b53e71-f4dd-42ed-beea-c31c171de1f7 34 fields · synced May 30, 2026