Identity
- Trade Name
- MR PHACO FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- I/A 150 Degree Tip ONLY, 16ga Outer Sleeve, 23ga Inner Cannula tip with .4mm front port, 20mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 45mm Overall Length, Stainless Steel FDA UDI
- Model / Reference
- PH85011 FDA UDI
- Description
- I/A 150 Degree Tip ONLY, 16ga Outer Sleeve, 23ga Inner Cannula tip with .4mm front port, 20mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 45mm Overall Length, Stainless Steel FDA UDI
Identifiers
- Primary DI / UDI-DI
- G412PH850110 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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- PANNU VISCO ASPIRATING CANNULA 22/23GA — Katena Products, Inc. · Class I
- Appasamy — APPASAMY ASSOCIATES PRIVATE LIMITED · Class IIa
- Mclntyre Anterior Chamber Cannula Angled Gauge 30 Stainless Steel — SURTEX INSTRUMENTS LTD · Class IIa
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- 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 83619823-be1e-4a58-8963-30f2bddaed41 33 fields · synced Jun 1, 2026