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: Koch Spatula and Karate Chopper DBL-Ended, Koch Spatula, .8mm Wide Gently Curved Shaft with Duckbill-Shaped tip / Katate Chopper with 1mm long cutting wedge for use in the LEFT hand, Angled 10mm from bend to tip, Round Knurled Handle, 126mm Overall Length, Stainless Steel FDA UDI
Model / Reference: PH6498L FDA UDI
Description: Koch Spatula and Karate Chopper DBL-Ended, Koch Spatula, .8mm Wide Gently Curved Shaft with Duckbill-Shaped tip / Katate Chopper with 1mm long cutting wedge for use in the LEFT hand, Angled 10mm from bend to tip, Round Knurled Handle, 126mm Overall Length, Stainless Steel FDA UDI

Identifiers

Primary DI / UDI-DI: G412PH6498L0 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 b61d0a1f-c529-45d9-a9b1-1472c1c91a46 33 fields · synced May 29, 2026