← Back to catalogue

Kirwan

FDA UDI

Class II (US FDA UDI)

by Kirwan Surgical Products Llc

Identity

Trade Name
Kirwan FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Device Name
Reusable Bipolar Forceps with Tips Angled 45 Degrees Up (Special) FDA UDI
Model / Reference
12-1035S FDA UDI
Description
Reusable Bipolar Forceps with Tips Angled 45 Degrees Up (Special) FDA UDI

Identifiers

Primary DI / UDI-DI
00841019121825 FDA UDI
510(k) Number
K811820 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam 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

K811820 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
Kirwan Surgical Products Llc

Sources (1)

  • FDA UDI b496b0c7-093b-4a5c-91f3-978de3cd7431 36 fields · synced Jun 1, 2026