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Phacofit

FDA UDI

Class I (US FDA UDI)

by Johnson & Johnson Surgical Vision, Inc.

Identity

Trade Name
PHACOFIT FDA UDI
Generic Name
Ophthalmic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Tip, Luer Adapter (Aspiration) FDA UDI
Model / Reference
OM05510115 FDA UDI
Description
Tip, Luer Adapter (Aspiration) FDA UDI

Identifiers

Catalog Number
OM05510115 FDA UDI
Primary DI / UDI-DI
05050474520561 FDA UDI
FDA Product Code
HMX FDA UDI
GMDN Term
Ophthalmic surgical procedure kit, non-medicated, 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

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic surgical procedure kit, non-medicated, reusable

Phacofit by Johnson & Johnson Surgical Vision, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Johnson & Johnson Surgical Vision, Inc.

Sources (1)

  • FDA UDI f62c1f10-0223-4a76-b3c8-837cbe2c5aac 35 fields · synced Jun 9, 2026