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Kirwan

FDA UDI

Class II (US FDA UDI)

by Kirwan Surgical Products Llc

Identity

Trade Name
Kirwan FDA UDI
Generic Name
Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Device Name
25cm Disposable Monopolar Electrode, Blunt Tip FDA UDI
Model / Reference
30-6022 FDA UDI
Description
25cm Disposable Monopolar Electrode, Blunt Tip FDA UDI

Identifiers

Primary DI / UDI-DI
00841019116500 FDA UDI
510(k) Number
K895331 FDA UDI
FDA Product Code
JOS FDA UDI
GMDN Term
Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Kirwan by Kirwan Surgical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K895331 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kirwan Surgical Products Llc

Sources (1)

  • FDA UDI 25bdc822-6ef5-4eda-bc99-29e01b3e5366 36 fields · synced Jun 1, 2026