Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT

FDA UDI

Class II (US FDA UDI)

by Alcon Laboratories, Inc.

Identity

Trade Name: Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT FDA UDI
Generic Name: Vitrectomy system handpiece FDA UDI
Device Name: 27+ TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator FDA UDI
Model / Reference: 8065752439 FDA UDI
Description: 27+ TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator FDA UDI

Identifiers

Primary DI / UDI-DI: 00380657524396 FDA UDI
FDA Product Code: MLZ FDA UDI
GMDN Term: Vitrectomy system handpiece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4150 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vitrectomy system handpiece

Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT by Alcon Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vitrectomy system handpiece.

AMO TAC INFUSION SLEEVE — Johnson & Johnson Surgical Vision, Inc. · Class II
DISPOSABLE 23GA VITRECTOMY CUTTER — Johnson & Johnson Surgical Vision, Inc. · Class II
INTRECTOR® — INSIGHT INSTRUMENTS, INC. · Class II
DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI — Johnson & Johnson Surgical Vision, Inc. · Class II
AMO VITREPURE VITRECTOMY HANDPIECES AND — Johnson & Johnson Surgical Vision, Inc. · Class II
AMO LIMBAL NEEDLE ASSEMBLY — Johnson & Johnson Surgical Vision, Inc. · Class II
AMO TAC VITRECTOMY HANDPIECE — Johnson & Johnson Surgical Vision, Inc. · Class II
DISPOSABLE 25GA VITRECTOMY CUTTER — Johnson & Johnson Surgical Vision, Inc. · Class II

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Alcon Laboratories, Inc.

Sources (1)

FDA UDI 793c7ae0-2701-4cad-b800-0a30455ce39a 34 fields · synced Jun 8, 2026