en - AutoShield Trocar, Smooth, 10x100mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PS4560ULTModel 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: en - AutoShield Trocar, Smooth, 10x100mm EUDAMED
Ultimate Auto-shield trocar with smooth cannula FDA UDI
Generic Name: Laparoscopic access cannula, single-use FDA UDI
Device Name: Autoshield Trocar EUDAMED
The Ultimate Auto Shield 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
PS4560ULT EUDAMEDFDA UDI
Description: The Ultimate Auto Shield 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: PS4560ULT FDA UDI
Primary DI / UDI-DI: 05051223015260 EUDAMEDFDA UDI
Basic UDI-DI: B-05051223015260 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

en - AutoShield Trocar, Smooth, 10x100mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited…

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-05051223015260	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 af07c08a-28b9-4b29-a6fb-1360ea87a76b 61 fields · synced Oct 8, 2026
FDA UDI a01e31c3-e36f-4b30-8d9f-95b46fbd4a1c 36 fields · synced May 30, 2026