Identity
- Trade Name
- ROSEN PHACO SPLITTER FDA UDI
- Generic Name
- Ophthalmic surgical probe, reusable FDA UDI
- Device Name
- ROSEN PHACO SPLITTER FDA UDI
- Model / Reference
- AE-2578 FDA UDI
- Description
- ROSEN PHACO SPLITTER FDA UDI
Identifiers
- Catalog Number
- AE-2578 FDA UDI
- Primary DI / UDI-DI
- 00841668130230 FDA UDI
- FDA Product Code
- HND FDA UDI
- GMDN Term
- Ophthalmic surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic surgical probe, reusable
Rosen Phaco Splitter by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Katena Products, Inc.
Sources (1)
- FDA UDI 4cd4acf2-6eac-44f2-9e37-dd3c46ceb8e7 35 fields · synced Jun 12, 2026