Identity
- Trade Name
- MR PHACO FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- Replacement O-ring sets for Titanium Handpieces; 1 Pack contains 5 of each of 4 different sizes FDA UDI
- Model / Reference
- PH8515T FDA UDI
- Description
- Replacement O-ring sets for Titanium Handpieces; 1 Pack contains 5 of each of 4 different sizes FDA UDI
Identifiers
- Primary DI / UDI-DI
- G412PH8515T0 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, 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 irrigation/infusion/aspiration cannula, non-illuminating, reusable
Mr Phaco by Crestpoint Management Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable.
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- Appasamy — APPASAMY ASSOCIATES PRIVATE LIMITED · Class IIa
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- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
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 5a10a082-a2b0-4cc0-b2c6-2a830fe6d442 33 fields · synced May 31, 2026