Identity
- Trade Name
- Swiss Coaxial I/A FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery. FDA UDI
- Model / Reference
- SMS355P FDA UDI
- Description
- The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery. FDA UDI
Identifiers
- Catalog Number
- SMS355P FDA UDI
- Primary DI / UDI-DI
- 07640123277151 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Swiss Coaxial I/A by Medicel AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Medicel AG
Sources (1)
- FDA UDI ba89214b-0ab2-4e80-a38a-df88358cfcdc 36 fields · synced May 31, 2026