AccessGUDID - DEVICE: Constellation, Ultravit, TotalPlus, Engauge (00380657510658)

GUDID

Device Identifier (DI) Information

Brand Name: Constellation, Ultravit, TotalPlus, Engauge
Version or Model: 8065751065
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380657510658
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 23 GA TotalPlus Combined Procedure Pak Engauge RFID 1.1 mm Tipless Anterior Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45073	Phacoemulsification/vitrectomy system generator	A mains electricity (AC-powered) ophthalmic device, that is a component of a system, that generates the energies (e.g., ultrasonic, piezoelectric, high frequency current) delivered through handpieces/tips that are introduced through an incision(s) made in the eye, for the purposes of performing combined phacoemulsification and/or vitrectomy (the removal and replacement of cataracts and/or the vitreous in anterior and posterior segment surgical procedures). It will typically be activated by the surgeon using a foot-switch and may include an irrigation/suction system for the removal of debris, a tamponade system (e.g., silicone and air), a diathermy device, and an intraocular illuminator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQE	Instrument, vitreous aspiration and cutting, ac-powered
HQC	Unit, phacofragmentation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 23 Gauge

Device Record Status

Public Device Record Key: 217ad57d-6081-428b-a2ec-1400644e69e0
Public Version Date: March 22, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2016