Mr Phaco

FDA UDI

Class I (US FDA UDI)

by Crestpoint Management Ltd.

Identity

Trade Name: MR PHACO FDA UDI
Generic Name: Intraocular retractor, reusable FDA UDI
Device Name: Graether Collar Button-Handle Model Iris retractor and capsule polisher with roughened posterior surface, Angled 10mm from bend to tip, Round Knurled Handle, 115mm Overall Length, Stainless Steel FDA UDI
Model / Reference: H1735 FDA UDI
Description: Graether Collar Button-Handle Model Iris retractor and capsule polisher with roughened posterior surface, Angled 10mm from bend to tip, Round Knurled Handle, 115mm Overall Length, Stainless Steel FDA UDI

Identifiers

Primary DI / UDI-DI: G412H17350 FDA UDI
FDA Product Code: HNI FDA UDI
GMDN Term: Intraocular retractor, 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: Intraocular retractor, reusable

Mr Phaco by Crestpoint Management Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraocular retractor, reusable.

Novo Surgical — NOVO SURGICAL, INC. · Class I
Bausch + Lomb — Bausch & Lomb Incorporated · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Hayden Medical — Hayden Medical Inc · Class I
GRAETHER MICRO IRIS RETRACTOR — SONTEC INSTRUMENTS, INC. · Class I
GRAETHER IRIS RETRACTOR ANGLED — Katena Products, Inc. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Iris Retractor — Katena Products, Inc. · 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

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Manufacturer

Manufacturer: Crestpoint Management Ltd.

Sources (1)

FDA UDI b4b43636-ca42-41ad-9208-b900968f948e 33 fields · synced May 30, 2026