Identity
- Trade Name
- Irrigation Tube FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- Irrigation and/or aspiration lines EUDAMED
- Model / Reference
- ZA02630020 EUDAMEDODG05599E5ST35 FDA UDI
Identifiers
- Catalog Number
- Y1500070 FDA UDI
- Primary DI / UDI-DI
- 03700512905196 EUDAMEDFDA UDI
- Basic UDI-DI
- 037005129GSU-IAX9 EUDAMED
- FDA Product Code
- GBX 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 I FDA UDI
- Regulation Number
- 878.4200 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Category: Surgical irrigation/aspiration tubing set
Irrigation Tube by Promepla — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- LAMIS "Y" Tubing — Mentor Texas LP · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Promepla
Sources (2)
- FDA UDI d4140449-9e73-40df-9a08-258479e4c185 33 fields · synced Jul 18, 2026
- EUDAMED 1d99be9c-99a0-481d-a0bb-d87feb730a2f 61 fields · synced Jul 18, 2026