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Laparoscopic Suction/Irrigation Set with 5mm × 320mm probe, Single Spike
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PS3851ULTModel TF-1034
Identity
- Trade Name
- Laparoscopic Suction/Irrigation Set with 5mm × 320mm probe, Single Spike EUDAMEDUltimate Laparoscopic Suction/Irrigation Set, Single spike FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- Laparoscopic Suction/Irrigation Set EUDAMEDSuction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument. FDA UDI
- Model / Reference
- TF-1034 EUDAMEDPS3851ULT EUDAMEDFDA UDI
- Description
- Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument. FDA UDI
Identifiers
- Catalog Number
- PS3851ULT FDA UDI
- Primary DI / UDI-DI
- 05051223005773 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051223005773 EUDAMED
- FDA Product Code
- HET FDA UDI
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1720 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
No
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
- Length — 320 Millimeter FDA UDI
Laparoscopic Suction/Irrigation Set with 5mm × 320mm probe, Single Spike by Purple Surgical Holdings Limited also known as Purple Surgical International…
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-05051223005773 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED b51a1444-424f-4eae-a370-ab18fe6c4841 61 fields · synced Oct 6, 2026
- FDA UDI d602886e-2a3e-448f-b557-b239713ed09b 36 fields · synced May 30, 2026