AccessGUDID - DEVICE: OPTI-FREE PUREMOIST (00300650192316)

GUDID

Device Identifier (DI) Information

Brand Name: OPTI-FREE PUREMOIST
Version or Model: OPTI-FREE PUREMOIST 12ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00300650192316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: OPTI-FREE PUREMOIST Rewetting Drops 12ml

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):	No
Over the Counter (OTC):	Yes
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?
48082	Contact lens wetting solution	An aqueous formulation intended to wet contact lenses. The device is dispensed as droplets typically directly on the eyes while the patient wears the contact lenses; it is available in single- or multiple-dose containers. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPN	Accessories, soft lens products

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
No Device Sizes

Device Record Status

Public Device Record Key: c25066b9-6b50-4d1f-8ba1-3a75cb12985b
Public Version Date: January 24, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016