Mr Phaco

FDA UDI

Class I (US FDA UDI)

by Crestpoint Management Ltd.

Identity

Trade Name: MR PHACO FDA UDI
Generic Name: Soft-tissue surgical hook, reusable FDA UDI
Device Name: Lubeck Horizontal Chopper/Nucleus Sustainer DBL-Ended, Akahoshi Nucleus Sustainer, Micro-Ball shaped tip for rotating and manipulating the lens, Angled 10mm from bend to tip / Nagahara Phaco Chopper 60 Degree Cutting Edge, Angled 10mm from bend to tip, Round Knurled Handle, 126mm Overall Length, Stainless Steel FDA UDI
Model / Reference: PH6600 FDA UDI
Description: Lubeck Horizontal Chopper/Nucleus Sustainer DBL-Ended, Akahoshi Nucleus Sustainer, Micro-Ball shaped tip for rotating and manipulating the lens, Angled 10mm from bend to tip / Nagahara Phaco Chopper 60 Degree Cutting Edge, Angled 10mm from bend to tip, Round Knurled Handle, 126mm Overall Length, Stainless Steel FDA UDI

Identifiers

Primary DI / UDI-DI: G412PH66000 FDA UDI
FDA Product Code: HNQ FDA UDI
GMDN Term: Soft-tissue surgical hook, 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Soft-tissue surgical hook, 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 7a40e82b-6f0f-4f02-aee2-b6fe37579e77 33 fields · synced May 30, 2026