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Irrigating Bipolar Coagulation Forceps 6 1/4 in. (15.9cm) Yasargil Bayonet, 0.7…

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 20-1311

by Kirwan Surgical Products LLC

Identity

Trade Name
Kirwan FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Device Name
Irrigating Bipolar Coagulation Forceps 6 1/4 in. (15.9cm) Yasargil Bayonet, 0.7mm tip EUDAMED
Irrigating Bipolar Coagulation Forceps 6 1/4" (15.9cm) Yasargil Bayonet, 0.7mm Tip FDA UDI
Model / Reference
20-1311 EUDAMEDFDA UDI
Description
Irrigating Bipolar Coagulation Forceps 6 1/4" (15.9cm) Yasargil Bayonet, 0.7mm Tip FDA UDI

Identifiers

Primary DI / UDI-DI
00841019105078 EUDAMEDFDA UDI
Basic UDI-DI
B-00841019105078 EUDAMED
510(k) Number
K811820 FDA UDI
FDA Product Code
GEI FDA UDI
EMDN Code
L180401 OPEN ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Dimensions & Sizes

Size
Length — 6.25 Inch FDA UDI

Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Irrigating Bipolar Coagulation Forceps 6 1/4 in. (15.9cm) Yasargil Bayonet, 0.7… by Kirwan Surgical Products Llc — Class IIb — MDD, FDA UDI — listed in…

Similar devices

Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
US-MF-000008222
Authorised Representative
MPS Medical Product Service GmbH DE-AR-000005009

Sources (2)

  • EUDAMED c90acb47-17e8-4ffb-897f-d36092f15ad6 61 fields · synced Jul 10, 2026
  • FDA UDI 0fc100ed-9e6d-4b60-928a-8a28a30ed645 36 fields · synced May 30, 2026