5mm x 440mm probe for PS3850ULT/PS3851ULT Laparoscopic Suction/Irrigation Set

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PS3845ULTModel TF-1034

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

Identity

Trade Name: 5mm x 440mm probe for PS3850ULT/PS3851ULT Laparoscopic Suction/Irrigation Set EUDAMED
Ulimate Suction/Irrigation probe FDA UDI
Generic Name: Surgical irrigation/aspiration tubing set FDA UDI
Device Name: Probe for Laparoscopic Irrigation Set EUDAMED
The probe attached to the Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument. FDA UDI
Model / Reference: TF-1034 EUDAMED
PS3845ULT EUDAMEDFDA UDI
Description: The probe attached to the Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument. FDA UDI

Identifiers

Catalog Number: PS3845ULT FDA UDI
Primary DI / UDI-DI: 05051223007944 EUDAMEDFDA UDI
Basic UDI-DI: B-05051223007944 EUDAMED
FDA Product Code: HET FDA UDI
EMDN Code: A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
GMDN Term: Surgical irrigation/aspiration tubing set FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 884.1720 FDA UDI
Market of Registration: Spain EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 440 Millimeter FDA UDI

5mm x 440mm probe for PS3850ULT/PS3851ULT Laparoscopic Suction/Irrigation Set by Purple Surgical Holdings Limited also known as Purple Surgical International…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-05051223007944	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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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 ec42f144-dd2e-4fa0-a4ae-3db65b286e05 61 fields · synced Oct 6, 2026
FDA UDI 25582692-6c3e-4048-8612-354c35feee00 36 fields · synced May 30, 2026