Identity

Trade Name
Monopolar Instrument cable with 4mm connector EUDAMED
Monopolar cable with 4mm connector FDA UDI
Generic Name
Electrical-only medical device connection cable, single-use FDA UDI
Device Name
Monopolar Instrument Cable EUDAMED
The Monopolar Cables are for use with a variety of Monopolar instruments with a universal offset diathermy post connection & compatible for use with a wide variety of makes of electrosurgical diathermy generators. FDA UDI
Model / Reference
TF-1002 EUDAMED
PS3551C4 EUDAMEDFDA UDI
Description
The Monopolar Cables are for use with a variety of Monopolar instruments with a universal offset diathermy post connection & compatible for use with a wide variety of makes of electrosurgical diathermy generators. FDA UDI

Identifiers

Catalog Number
PS3551C8 FDA UDI
Primary DI / UDI-DI
05051223005926 EUDAMEDFDA UDI
Basic UDI-DI
B-05051223005926 EUDAMED
FDA Product Code
GEI FDA UDI
EMDN Code
K02010203 ELECTROSURGERY CONNECTION CABLES, SINGLE-USE EUDAMED
GMDN Term
Electrical-only medical device connection cable, single-use FDA UDI

Classification

Device Class
Class I 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 — 3 Meter FDA UDI

Category: Electrical-only medical device connection cable, reusable

Monopolar Instrument cable with 4mm connector by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK…

Similar devices

Also classified as Electrical-only medical device connection cable, 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
GB-MF-000012819
Authorised Representative
Advena Limited MT-AR-000000234

Sources (3)

  • EUDAMED ffbc064a-39cb-4e7b-978a-c3c68d3b16b8 61 fields · synced Oct 6, 2026
  • FDA UDI 6fb3fbc1-60be-4826-8566-040d76a0d7f1 36 fields · synced May 30, 2026
  • EUDAMED 90fc5dd5-8106-47cc-9a20-49d6093a4df3 61 fields · synced Oct 6, 2026