Smartload

FDA UDI

Class III (US FDA UDI)

by Johnson & Johnson Surgical Vision, Inc.

Identity

Trade Name: SMARTLOAD FDA UDI
Generic Name: Intraocular lens-insertion cartridge FDA UDI
Device Name: SMARTLOAD TECNIS 1PC CLEAR MONO 12.0D FDA UDI
Model / Reference: GCB00 FDA UDI
Description: SMARTLOAD TECNIS 1PC CLEAR MONO 12.0D FDA UDI

Identifiers

Catalog Number: GCB0000120 FDA UDI
Primary DI / UDI-DI: 05050474620445 FDA UDI
FDA Product Code: HQL FDA UDI
GMDN Term: Intraocular lens-insertion cartridge 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

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 Intraocular lens-insertion cartridge

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

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BL-Cart™ IOL Delivery Cartridge — Ast Products, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Johnson & Johnson Surgical Vision, Inc.

Sources (1)

FDA UDI cbbfbc6a-ea27-46bf-8b81-031a65ff3de5 37 fields · synced Jun 9, 2026