AccessGUDID - DEVICE: CONSTELLATION (00380657515400)

GUDID

Device Identifier (DI) Information

Brand Name: CONSTELLATION
Version or Model: 8065751540
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380657515400
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: BALLAST

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:	No
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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

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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 8efc69c4-2344-4865-a89d-87db062fd38b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016