AccessGUDID - DEVICE: OPTI-FREE PUREMOIST (00300650361040)

GUDID

Device Identifier (DI) Information

Brand Name: OPTI-FREE PUREMOIST
Version or Model: OPTI-FREE PUREMOIST 10oz
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00300650361040
Issuing Agency: GS1
Commercial Distribution End Date: June 29, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: Opti-Free Pure Moist Multi-Purpose Disinfecting Solution 10 oz.

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:	Yes
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?
45870	Multi-purpose soft contact lens solution	A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting reusable soft contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). 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: 7a4bf0ea-5d9f-4554-9613-0cd947213a09
Public Version Date: March 27, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2016