Universal Plus/Flovac
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- UNIVERSAL PLUS/FLOVAC EUDAMEDFDA UDI
- Generic Name
- Surgical irrigation/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Surgical Instruments and Accessories EUDAMEDUNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITH LASER ACCESS, CANNULA 5 MM X 32 CM FDA UDIUNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITH SIDE HOLES, CANNULA 5 MM X 32 CM FDA UDIUNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITH SIDE HOLES, CANNULA 5 MM X 44 CM FDA UDI
- Model / Reference
- 60-6001-203 EUDAMEDFDA UDI60-6001-205 EUDAMEDFDA UDI60-6001-360 FDA UDI
- Description
- UNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITH LASER ACCESS, CANNULA 5 MM X 32 CM FDA UDIUNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITH SIDE HOLES, CANNULA 5 MM X 32 CM FDA UDIUNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITH SIDE HOLES, CANNULA 5 MM X 44 CM FDA UDI
Identifiers
- Catalog Number
- 60-6001-360 FDA UDI60-6001-203 FDA UDI60-6001-205 FDA UDI
- Primary DI / UDI-DI
- 30653405011457 EUDAMEDFDA UDI30653405011471 EUDAMEDFDA UDI30653405011488 FDA UDI
- Basic UDI-DI
- B-30653405011471 EUDAMEDB-30653405011457 EUDAMED
- 510(k) Number
- K960562 FDA UDI
- FDA Product Code
- GCJ FDA UDIGEI FDA UDI
- EMDN Code
- A06010103 CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE EUDAMED
- GMDN Term
- Surgical irrigation/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 10 Millimeter FDA UDILength — 32 Centimeter FDA UDILength — 44 Centimeter FDA UDI
Category: Surgical irrigation/aspiration cannula, non-illuminating, single-use
Universal Plus/Flovac by Conmed Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration cannula, non-illuminating, single-use.
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- Taiwan Surgical — Taiwan Surgical Corporation · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- Elefant — Coloplast A/S · Class II
- OSSEOUS Suction Tube - Fine Tip — EON MEDITECH PRIVATE LIMITED · Class I
Cleared under the same submission
K960562 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (5)
- FDA UDI f187145b-c5ba-4e02-8938-6d1f96d91b67 38 fields · synced Sep 17, 2026
- FDA UDI d5862392-c507-4d7b-95b5-193c4b493354 37 fields · synced May 30, 2026
- FDA UDI 3120dfca-b66b-480d-9827-85d1d9e3767d 37 fields · synced May 30, 2026
- EUDAMED bd243725-7c61-4ba5-bf7c-06b319dd334a 61 fields · synced Jul 27, 2026
- EUDAMED 46449cee-9d6c-4cb2-b20b-ac86a8277c42 61 fields · synced Sep 17, 2026