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Dilating Tip Trocar, Threaded, 5x100mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PS5465ULTModel TF-1020Ref PS5465ULTNSModel TF1020

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, Threaded, 5x100mm EUDAMED
Dilating Tip Trocar with Threaded cannula FDA UDI
Generic Name
Laparoscopic access cannula, single-use FDA UDI
Device Name
Dilating Tip Trocar EUDAMED
PRIMARY TROCARS - ULTIMATE 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
PS5465ULT EUDAMEDFDA UDI
TF1020 EUDAMED
PS5465ULTNS EUDAMED
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
PS5465ULT FDA UDI
Primary DI / UDI-DI
05051223015536 EUDAMEDFDA UDI
35051223034200 EUDAMED
Basic UDI-DI
B-05051223015536 EUDAMED
B-35051223034200 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
Northern Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMED

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

Dilating Tip Trocar, Threaded, 5x100mm 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

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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 (3)

  • EUDAMED 85d7cd97-a335-4b56-85e2-16f346cc57c6 61 fields · synced Oct 7, 2026
  • EUDAMED e76362cc-f8e2-4fe8-8f40-9751621ae8e1 61 fields · synced May 18, 2026
  • FDA UDI c68d9560-6fdf-48bf-9031-84cc75c39a48 36 fields · synced May 30, 2026