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Ppt Crystalens 12/Bx

FDA UDI

Class II (US FDA UDI)

by Bausch & Lomb, Inc.

Identity

Trade Name
PPT CRYSTALENS 12/BX FDA UDI
Generic Name
Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Single Use Medical Device for Ophthalmic Surgery FDA UDI
Model / Reference
PPT051 FDA UDI
Description
Single Use Medical Device for Ophthalmic Surgery FDA UDI

Identifiers

Catalog Number
PPT051 FDA UDI
Primary DI / UDI-DI
04058935000653 FDA UDI
FDA Product Code
OJK FDA UDI
GMDN Term
Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4790 FDA UDI
Commercial Distribution
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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic surgical procedure kit, non-medicated, single-use

Ppt Crystalens 12/Bx by Bausch & Lomb, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bausch & Lomb, Inc.

Sources (1)

  • FDA UDI b272d403-c1cd-43b7-91ee-47bd8dffea44 34 fields · synced May 30, 2026