1.20mm (18 Gauge) Thin Wall Aspiration Needle, 5mm shaft

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PS3895Model TF1023

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

Identity

Trade Name: 1.20mm (18 Gauge) Thin Wall Aspiration Needle, 5mm shaft EUDAMED
Aspiration Needle FDA UDI
Generic Name: Body aspiration needle, single-use FDA UDI
Device Name: ASPIRATION NEEDLE EUDAMED
The Aspiration Needle is for aspiration of fluids from cysts & abdominal organs during laparoscopic procedures. FDA UDI
Model / Reference: TF1023 EUDAMED
PS3895 EUDAMEDFDA UDI
Description: The Aspiration Needle is for aspiration of fluids from cysts & abdominal organs during laparoscopic procedures. FDA UDI

Identifiers

Catalog Number: PS3895 FDA UDI
Primary DI / UDI-DI: 05051223007418 EUDAMEDFDA UDI
Basic UDI-DI: B-05051223007418 EUDAMED
FDA Product Code: GAA FDA UDI
EMDN Code: A019009 DRAINAGE NEEDLES EUDAMED
GMDN Term: Body aspiration needle, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Market of Registration: Northern Ireland 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 290 Millimeter FDA UDI

1.20mm (18 Gauge) Thin Wall Aspiration Needle, 5mm shaft 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-05051223007418	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 15dd5034-d33c-43a2-9c40-236e9f3b3d92 61 fields · synced Oct 7, 2026
FDA UDI b62b97de-d528-4506-90f1-d7daac87184d 36 fields · synced May 30, 2026