Identity
- Trade Name
- MR PHACO FDA UDI
- Generic Name
- Ophthalmic surgical device handling forceps, reusable FDA UDI
- Device Name
- Utrata Capsulorrhexis Forceps SLIM Angled 13mm from bend to tip with Slim Shafts and Extremely Thin Triangular Grasping Tips, Serrated Flat Handle, 80mm Overall Length, Stainless Steel FDA UDI
- Model / Reference
- PH1020 FDA UDI
- Description
- Utrata Capsulorrhexis Forceps SLIM Angled 13mm from bend to tip with Slim Shafts and Extremely Thin Triangular Grasping Tips, Serrated Flat Handle, 80mm Overall Length, Stainless Steel FDA UDI
Identifiers
- Primary DI / UDI-DI
- G412PH1020 FDA UDI
- FDA Product Code
- HNR FDA UDI
- GMDN Term
- Ophthalmic surgical device handling forceps, reusable 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
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
Mr Phaco by Crestpoint Management Ltd. — 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
- Crestpoint Management Ltd.
Sources (1)
- FDA UDI 8b4f7274-780c-4659-a0c6-70aa669c2d88 34 fields · synced May 30, 2026