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Monopolar Electrode - Spatula, 5 mm × 33 cm

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref PS3882Model TF-1044

by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited

Identity

Trade Name
Monopolar Electrode - Spatula, 5 mm × 33 cm EUDAMED
Laparoscopic electrode - spatula FDA UDI
Generic Name
Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Device Name
Laparoscopic Electrode EUDAMED
The Laparoscopic Electrode is used during laparoscopic procedures through a port, for controlled coagulation and transection of vessels and tissue. FDA UDI
Model / Reference
TF-1044 EUDAMED
PS3882 EUDAMEDFDA UDI
Description
The Laparoscopic Electrode is used during laparoscopic procedures through a port, for controlled coagulation and transection of vessels and tissue. FDA UDI

Identifiers

Catalog Number
PS3882 FDA UDI
Primary DI / UDI-DI
05051223000860 EUDAMEDFDA UDI
Basic UDI-DI
B-05051223000860 EUDAMED
FDA Product Code
GEI FDA UDI
EMDN Code
K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
GMDN Term
Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 345 Millimeter FDA UDI

Monopolar Electrode - Spatula, 5 mm × 33 cm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited
EUDAMED SRN
GB-MF-000012819
Authorised Representative
Advena Limited MT-AR-000000234

Sources (2)

  • EUDAMED 348943af-f26c-4151-9a43-8e1e8ca6319c 61 fields · synced Oct 6, 2026
  • FDA UDI 27a3ee2b-1bad-4155-b636-f1b6f9e8eb79 36 fields · synced May 30, 2026