Identity
- Trade Name
- MR PHACO FDA UDI
- Generic Name
- Ophthalmic surgical device handling forceps, reusable FDA UDI
- Device Name
- Utrata MICS Capsulorhexis Cystotome Forceps, Designed to fit in 1.8mm incision, Angled 11mm from bend to tip with Extremely Thin Sharp Triangular Grasping Tips, Three Hole Flat Handle, 100mm Overall Length, Stainless Steel FDA UDI
- Model / Reference
- PH2703 FDA UDI
- Description
- Utrata MICS Capsulorhexis Cystotome Forceps, Designed to fit in 1.8mm incision, Angled 11mm from bend to tip with Extremely Thin Sharp Triangular Grasping Tips, Three Hole Flat Handle, 100mm Overall Length, Stainless Steel FDA UDI
Identifiers
- Primary DI / UDI-DI
- G412PH27030 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
- 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: Ophthalmic surgical device handling forceps, reusable
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 f39c030b-d60e-4747-ae4c-5db9deb441a1 33 fields · synced Jun 1, 2026