Identity
- Trade Name
- Laparoscopic Suction/ Irrigation Set single spike FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- The Laparoscopic 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
- Model / Reference
- PS3801 FDA UDI
- Description
- The Laparoscopic 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
- PS3801 FDA UDI
- Primary DI / UDI-DI
- 05051223004196 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Surgical irrigation/aspiration tubing set
Laparoscopic Suction/ Irrigation Set single spike by Purple Surgical International Limited — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Surgical irrigation/aspiration tubing set.
- LAMIS Tubing — Mentor Texas LP · Class I
- Aspiration Tubing — BLACK & BLACK SURGICAL, INC. · Class II
- MB ULTRA-LIMP TUBING — The Wells Johnson Company · Class II
- INFILTRATION TUBING — BLACK & BLACK SURGICAL, INC. · Class II
- Autofuse Tubing — Mentor Texas LP · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- ENDOFLOW II - PROBES - 4 holes diam.5 inch — Promepla · Class I
- Hysteroscopy set 2 spikes — Promepla · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Purple Surgical International Limited
Sources (1)
- FDA UDI cd5cd3e4-9f24-4c1e-8e98-7755567235c8 35 fields · synced May 30, 2026