AccessGUDID - DEVICE: iLux (00864461000401)

GUDID

Device Identifier (DI) Information

Brand Name: iLux
Version or Model: 2020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2020
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00864461000401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: No description.

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58217	Eyelid thermal pulsation system control unit	An electrically-powered ophthalmic device intended to control the application of heat and pressure (e.g., intermittent pressure massage) applied to the eyelids during treatment of lid margin disease (LMD), meibomian gland dysfunction (MGD) and/or evaporative dry eye. It typically includes controls, integrated software, and a visual display unit (VDU) and is designed to control the heat and pressure supply that are applied via an attached applicator (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORZ	Eyelid Thermal Pulsation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172645	000

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: aada5a5b-df68-42da-984c-03a3277477fd
Public Version Date: January 20, 2025
Public Version Number: 3
DI Record Publish Date: November 05, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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