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Disposable Phaco Pack

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
Disposable Phaco Pack FDA UDI
Generic Name
Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Model / Reference
3002.P2 FDA UDI

Identifiers

Catalog Number
3002.P2 FDA UDI
Primary DI / UDI-DI
08717872008929 FDA UDI
510(k) Number
K081877 FDA UDI
FDA Product Code
HQC FDA UDI
GMDN Term
Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4670 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Disposable Phaco Pack by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K081877 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

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

Sources (1)

  • FDA UDI 2375f59a-302c-45e2-8e1f-0ab69d876a36 35 fields · synced May 30, 2026