Transparent infusion sleeve for 3005.FDM phaco needles

FDA UDI

Class II (US FDA UDI)

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Identity

Trade Name: Transparent infusion sleeve for 3005.FDM phaco needles FDA UDI
Generic Name: Phacoemulsification system handpiece FDA UDI
Model / Reference: 3003.M FDA UDI

Identifiers

Catalog Number: 3003.M FDA UDI
Primary DI / UDI-DI: 08717872008967 FDA UDI
510(k) Number: K081877 FDA UDI
FDA Product Code: HQC FDA UDI
GMDN Term: Phacoemulsification system handpiece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4670 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

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: Phacoemulsification system handpiece

Transparent infusion sleeve for 3005.FDM phaco needles by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA…

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Also classified as Phacoemulsification system handpiece.

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ULITE PHACO HANDPIECE — Carl Zeiss Meditec AG · Class II
ELLIPS PHACO — Johnson & Johnson Surgical Vision, Inc. · Class II

Cleared under the same submission

K081877 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Sources (1)

FDA UDI 93f9ea53-f753-451c-b112-f78f263ca48f 34 fields · synced May 30, 2026