Identity
- Trade Name
- SMARTGUARD EUDAMEDFDA UDI
- Generic Name
- Surgical irrigation system nozzle FDA UDI
- Device Name
- Powered Surgical Instruments EUDAMEDSMARTGUARD IRRIGATOR FDA UDI
- Model / Reference
- 6020-260 EUDAMED00602026000 FDA UDI
- Description
- SMARTGUARD IRRIGATOR FDA UDI
Identifiers
- Catalog Number
- 6020-260 FDA UDI
- Primary DI / UDI-DI
- 10845854029343 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854029343 EUDAMED
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- K0380 ARTHROSCOPY DEVICES, SINGLE USE - ACCESSORIES EUDAMED
- GMDN Term
- Surgical irrigation system nozzle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Belgium 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
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 system nozzle
Smartguard by Conmed Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation system nozzle.
- AWI — Apex (Suzhou) Medical Products Company · Class II
- De Soutter Medical — De Soutter Medical, Ltd. · Class II
- De Soutter Medical — De Soutter Medical, Ltd. · Class II
- De Soutter Medical — De Soutter Medical, Ltd. · Class II
- Super Bypass — TAKAYAMA INSTRUMENTS INC. · Class I
- Super Bypass — TAKAYAMA INSTRUMENTS INC. · Class I
- itool® ApexPulse™ — Apex (Guangzhou) Tools & Orthopedics Co. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conmed Corporation
Sources (2)
- FDA UDI 6dfb7074-d663-4675-a234-1d0ce6e1ec86 36 fields · synced Jul 9, 2026
- EUDAMED bcddeb7f-4d79-4929-b57f-2536986340f6 61 fields · synced Jul 9, 2026