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Bausch + Lomb

FDA UDI

Class I (US FDA UDI)

by Bausch & Lomb Incorporated

Identity

Trade Name
Bausch + Lomb FDA UDI
Generic Name
Intraocular lens-insertion cartridge FDA UDI
Device Name
SimplifEYE inserter for enVista Preloaded FDA UDI
Model / Reference
SimplifEYE for enVista FDA UDI
Description
SimplifEYE inserter for enVista Preloaded FDA UDI

Identifiers

Primary DI / UDI-DI
00757770571758 FDA UDI
FDA Product Code
MSS FDA UDI
GMDN Term
Intraocular lens-insertion cartridge FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4300 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

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

Category: Intraocular lens-insertion cartridge

Bausch + Lomb by Bausch & Lomb Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraocular lens-insertion cartridge.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bausch & Lomb Incorporated

Sources (1)

  • FDA UDI 66b9c897-ffb5-48db-bd9d-19bd8eeb4aff 33 fields · synced Jun 8, 2026