Identity
- Trade Name
- MR PHACO FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- Gills Irrigating-Aspirating Cannula, Dual Hub Constructions, 23gatw IRR and 25ga ASP, Angled 30 Degrees, 8mm from Tip to Bend, Irrigation Tip is set .5mm behind Aspiration Tip, 23mm Overall Length FDA UDI
- Model / Reference
- CA1469 FDA UDI
- Description
- Gills Irrigating-Aspirating Cannula, Dual Hub Constructions, 23gatw IRR and 25ga ASP, Angled 30 Degrees, 8mm from Tip to Bend, Irrigation Tip is set .5mm behind Aspiration Tip, 23mm Overall Length FDA UDI
Identifiers
- Primary DI / UDI-DI
- G412CA14690 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
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable.
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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 090b8bd8-7645-4a96-a768-c641108604af 33 fields · synced Jun 6, 2026