Identity
- Trade Name
- MR PHACO FDA UDI
- Generic Name
- General-purpose surgical spatula FDA UDI
- Device Name
- Castroviejo Cyclodialysis DBL/Ended Spatula, .5mm flat posterior surface with Semi-Sharp tip Angled/Vaulted 10mm from bend to tip / .5mm flat posterior surface with Semi-Sharp tip, Angled/Vaulted 15mm from bend to tip, Round Handle, 135 mm Overall Length, Stainless Steel FDA UDI
- Model / Reference
- H1805 FDA UDI
- Description
- Castroviejo Cyclodialysis DBL/Ended Spatula, .5mm flat posterior surface with Semi-Sharp tip Angled/Vaulted 10mm from bend to tip / .5mm flat posterior surface with Semi-Sharp tip, Angled/Vaulted 15mm from bend to tip, Round Handle, 135 mm Overall Length, Stainless Steel FDA UDI
Identifiers
- Primary DI / UDI-DI
- G412H18050 FDA UDI
- FDA Product Code
- HND FDA UDI
- GMDN Term
- General-purpose surgical spatula 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General-purpose surgical spatula
Mr Phaco by Crestpoint Management Ltd. — 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
- Crestpoint Management Ltd.
Sources (1)
- FDA UDI de410f64-428b-416a-9881-85231a7e8ff1 33 fields · synced May 30, 2026