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Smartload

FDA UDI

Class III (US FDA UDI)

by Johnson & Johnson Surgical Vision, Inc.

Identity

Trade Name
SMARTLOAD FDA UDI
Generic Name
Posterior-chamber intraocular lens, pseudophakic FDA UDI
Device Name
SMARTLOAD TECNIS EYHANCE US IOL 21.0D FDA UDI
Model / Reference
GIB00 FDA UDI
Description
SMARTLOAD TECNIS EYHANCE US IOL 21.0D FDA UDI

Identifiers

Catalog Number
GIB00U0210 FDA UDI
Primary DI / UDI-DI
05050474829893 FDA UDI
FDA Product Code
HQL FDA UDI
GMDN Term
Posterior-chamber intraocular lens, pseudophakic FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
886.3600 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 13.00 Millimeter FDA UDI

Category: Posterior-chamber intraocular lens, pseudophakic

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

Similar devices

Also classified as Posterior-chamber intraocular lens, pseudophakic.

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 036acad0-3fbe-4233-ac82-7299dc1e55af 37 fields · synced Jun 9, 2026