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: Jaffe Lid Retractor .035 Stainless Wire, 15mm Closed Blade with curved shafts, 2 pieces per set, 55mm Overall Length FDA UDI
Model / Reference: PH6201 FDA UDI
Description: Jaffe Lid Retractor .035 Stainless Wire, 15mm Closed Blade with curved shafts, 2 pieces per set, 55mm Overall Length FDA UDI

Identifiers

Primary DI / UDI-DI: G412PH62010 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

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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 94355378-17ea-4c41-891d-6dc08ff47d1c 33 fields · synced May 30, 2026