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Sterile Irrigation Tube Kit - C Shank, High Flow Rate
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref S101461
by Zethon Ltd
Identity
- Trade Name
- Zethon FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- STERILE IRRIGATION TUBE KIT - C SHANK, HIGH FLOW RATE EUDAMEDSTERILE IRRIGATION TUBE KIT - C SHANK FDA UDI
- Model / Reference
- S101461 EUDAMEDFDA UDI
- Description
- STERILE IRRIGATION TUBE KIT - C SHANK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05059358034989 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05059358034989 EUDAMED
- 510(k) Number
- K233958 FDA UDI
- FDA Product Code
- HBE FDA UDI
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic bur, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4310 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
MR Unsafe FDA UDI
Sterile Irrigation Tube Kit - C Shank, High Flow Rate by Zethon Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05059358034989 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Zethon Ltd
- EUDAMED SRN
- GB-MF-000014309
- Authorised Representative
- De Soutter Medical Limited NL-AR-000000438
Sources (2)
- EUDAMED 7631d76e-8427-408e-944f-f3d4fd617ab9 61 fields · synced Jul 23, 2026
- FDA UDI 474c5135-5f23-4137-9054-f6c869ed02ff 34 fields · synced May 25, 2026