Identity
- Trade Name
- MR PHACO FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- I/A Silicone 90 Degree Tip ONLY, Silicone Outer Sleeve, 19ga Closed Inner Cannula tip with .3mm Aspirating Port, 21mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 45mm Overall Length, Stainless Steel FDA UDI
- Model / Reference
- PH8509T FDA UDI
- Description
- I/A Silicone 90 Degree Tip ONLY, Silicone Outer Sleeve, 19ga Closed Inner Cannula tip with .3mm Aspirating Port, 21mm 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
- G412PH8509T0 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 6f4ae28b-918d-4ace-a7fa-c0a6414f4e2d 33 fields · synced May 31, 2026