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Irrigation/Aspiration set 1 spike - with handpiece & probe tip, 5mmx33cm
FDA UDIClass II (US FDA UDI)
by Promepla
Identity
- Trade Name
- Irrigation/Aspiration set 1 spike - with handpiece & probe tip, 5mmx33cm FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Model / Reference
- RF04015 FDA UDI
Identifiers
- Catalog Number
- RF04015 FDA UDI
- Primary DI / UDI-DI
- 03700512901594 FDA UDI
- FDA Product Code
- FHF FDA UDI
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4370 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
Irrigation/Aspiration set 1 spike - with handpiece & probe tip, 5mmx33cm by Promepla — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration tubing set.
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- 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 (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
- Promepla
Sources (1)
- FDA UDI a3550f9e-e0cd-4bcc-9a67-e3b551e1d1ca 34 fields · synced May 30, 2026