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Weck

FDA UDI

Class II (US FDA UDI)

by Kirwan Surgical Products Llc

Identity

Trade Name
Weck FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Device Name
Bipolar Electrosurgical Forceps Cushing 7.5" (19.1cm), Bayonet, Insulated Straight Tips (1mm) FDA UDI
Model / Reference
392036 FDA UDI
Description
Bipolar Electrosurgical Forceps Cushing 7.5" (19.1cm), Bayonet, Insulated Straight Tips (1mm) FDA UDI

Identifiers

Primary DI / UDI-DI
00841019110287 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 7.5 Inch FDA UDI

Weck 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

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Manufacturer

Manufacturer
Kirwan Surgical Products Llc

Sources (1)

  • FDA UDI 2aa37995-3ed5-43ac-a9f6-7d9853c5ae80 37 fields · synced Jun 1, 2026