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Threaded Cannula, 12x100mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PS5566ULTModel 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
Threaded Cannula, 12x100mm EUDAMED
Universal Threaded Cannula FDA UDI
Generic Name
Laparoscopic access cannula, single-use FDA UDI
Device Name
Universal Cannula EUDAMED
The Ultimate Cannula has applications in minimally invasive surgical procedures, and acts as a port of entry for endoscopic instruments. FDA UDI
Model / Reference
TF-1020 EUDAMED
PS5566ULT EUDAMEDFDA UDI
Description
The Ultimate Cannula has applications in minimally invasive surgical procedures, and acts as a port of entry for endoscopic instruments. FDA UDI

Identifiers

Catalog Number
PS5566ULT FDA UDI
Primary DI / UDI-DI
05051223024514 EUDAMEDFDA UDI
Basic UDI-DI
B-05051223024514 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

Threaded Cannula, 12x100mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and 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 7042448e-1cd2-40cb-bbdc-9f938e6c58fc 61 fields · synced Oct 6, 2026
  • FDA UDI fe236f8c-e193-4d34-8577-533e24e7da64 36 fields · synced May 30, 2026