Dilating Tip Trocar, Smooth, 12x100mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PS4462ULTModel TF-1020

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

Identity

Trade Name: Dilating Tip Trocar, Smooth, 12x100mm EUDAMED
Ultimate Dilating tip trocar with smooth cannula FDA UDI
Generic Name: Laparoscopic access cannula, single-use FDA UDI
Device Name: Dilating Trocar EUDAMED
The Ultimate Dilating Tip Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions. FDA UDI
Model / Reference: TF-1020 EUDAMED
PS4462ULT EUDAMEDFDA UDI
Description: The Ultimate Dilating Tip Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions. FDA UDI

Identifiers

Catalog Number: PS4462ULT FDA UDI
Primary DI / UDI-DI: 05051223015208 EUDAMEDFDA UDI
Basic UDI-DI: B-05051223015208 EUDAMED
FDA Product Code: HET FDA UDI
EMDN Code: K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
GMDN Term: Laparoscopic access cannula, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 884.1720 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

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

Dilating Tip Trocar, Smooth, 12x100mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and…

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-05051223015208	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 6f633609-5e07-4927-bb5f-6120e3bf4f8d 61 fields · synced Oct 6, 2026
FDA UDI ac98ac99-b11e-46a9-9fea-b0b1e1dc915f 36 fields · synced May 25, 2026