Mr Phaco

FDA UDI

Class I (US FDA UDI)

by Crestpoint Management Ltd.

Identity

Trade Name: MR PHACO FDA UDI
Generic Name: General-purpose surgical spatula FDA UDI
Device Name: Carones LASEK Spatula DBL-Ended, LARGE Spatula, The Arc of the spatula represents a 30 Degree section of a 9mm optical zone, Angled 4mm from bend to tip, / SMALL Spatula, The Arc of the spatula represents a 30 Degree section of a 7mm optical zone, Angled 3mm from bend to tip, Round Knurled Handle, 126mm Overall Length, Stainless Steel FDA UDI
Model / Reference: PH6141 FDA UDI
Description: Carones LASEK Spatula DBL-Ended, LARGE Spatula, The Arc of the spatula represents a 30 Degree section of a 9mm optical zone, Angled 4mm from bend to tip, / SMALL Spatula, The Arc of the spatula represents a 30 Degree section of a 7mm optical zone, Angled 3mm from bend to tip, Round Knurled Handle, 126mm Overall Length, Stainless Steel FDA UDI

Identifiers

Primary DI / UDI-DI: G412PH61410 FDA UDI
FDA Product Code: HND FDA UDI
GMDN Term: General-purpose surgical spatula 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: General-purpose surgical spatula

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 2a09729b-cf84-4b94-97b4-7b42fbef3dca 33 fields · synced May 30, 2026