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Tissue Retrieval Pouch, 125 × 175 mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PS3401Model TF-1028

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

Identity

Trade Name
Tissue Retrieval Pouch, 125 × 175 mm EUDAMED
Tissue Retrieval pouch large FDA UDI
Generic Name
Tissue extraction bag FDA UDI
Device Name
Tissue Retrieval Pouch EUDAMED
The Tissue Retrieval Pouch is used during laparoscopic procedures for retrieving tissue specimens from the abdominal cavity. FDA UDI
Model / Reference
TF-1028 EUDAMED
PS3401 EUDAMEDFDA UDI
Description
The Tissue Retrieval Pouch is used during laparoscopic procedures for retrieving tissue specimens from the abdominal cavity. FDA UDI

Identifiers

Catalog Number
PS3401 FDA UDI
Primary DI / UDI-DI
05051223000655 EUDAMEDFDA UDI
Basic UDI-DI
B-05051223000655 EUDAMED
FDA Product Code
KGY FDA UDI
EMDN Code
K01020107 MINIMALLY INVASIVE SURGERY RECOVERY BAGS EUDAMED
GMDN Term
Tissue extraction bag FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
878.4100 FDA UDI
Market of Registration
Spain 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 500 Milliliter FDA UDI
Length — 175 Millimeter FDA UDI
Width — 125 Millimeter FDA UDI

Tissue Retrieval Pouch, 125 × 175 mm 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 (2)

  • EUDAMED 124789ea-76c9-4e5c-9dce-a5e7d919c574 61 fields · synced Oct 6, 2026
  • FDA UDI 9145cdec-0981-4efe-92fa-2660a99e0ba4 36 fields · synced May 25, 2026