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: Seibel LASIK Flap Lifter & Spatula DBL-Ended, Lasik Flap Lifter, Flattened Slightly Pointed Tear-Drop shaped tip, Angled 7mm from bend to tip, / Spatula, Flattened Unique Beaver-Tail Shaped tip, Angled/Vaulted 10mm from bend to tip, Round Knurled Handle, 94mm Overall Length, Stainless Steel FDA UDI
Model / Reference: PH6139 FDA UDI
Description: Seibel LASIK Flap Lifter & Spatula DBL-Ended, Lasik Flap Lifter, Flattened Slightly Pointed Tear-Drop shaped tip, Angled 7mm from bend to tip, / Spatula, Flattened Unique Beaver-Tail Shaped tip, Angled/Vaulted 10mm from bend to tip, Round Knurled Handle, 94mm Overall Length, Stainless Steel FDA UDI

Identifiers

Primary DI / UDI-DI: G412PH61390 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

Similar devices

Also classified as General-purpose surgical spatula.

Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
Sklar® — Sklar Corporation · Class I
ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
Bausch + Lomb — Bausch & Lomb Incorporated · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
MicroFrance® — Integra Microfrance · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Crestpoint Management Ltd.

Sources (1)

FDA UDI b14c0816-87c1-4481-8d7c-6d0413aba933 33 fields · synced May 30, 2026