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AutoShield Trocar, Smooth, plus Extra Cannula, 5x100mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PS4563ULTModel 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
AutoShield Trocar, Smooth, plus Extra Cannula, 5x100mm EUDAMED
Ultimate Auto-Shield Trocar with smooth cannula + Additional 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
PS4563ULT 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
PS4563ULT FDA UDI
Primary DI / UDI-DI
05051223015291 EUDAMEDFDA UDI
Basic UDI-DI
B-05051223015291 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

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

AutoShield Trocar, Smooth, plus Extra Cannula, 5x100mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple…

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 34d5cba2-4891-4178-b174-6b48fbd9069b 61 fields · synced Oct 6, 2026
  • FDA UDI f5fc0e08-4bd1-4d85-b626-c811f6ca7448 36 fields · synced May 30, 2026