AccessGUDID - DEVICE: Deep Well Lens Case (Ribbed) (B222600)

GUDID

Device Identifier (DI) Information

Brand Name: Deep Well Lens Case (Ribbed)
Version or Model: 600
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Paragon Vision Sciences, Inc.

Primary DI Number: B222600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 028594987 *Terms of Use

Device Description: Deep Well Lens Cases are fabricated from a low-density polyethylene plastic resin and have a ribbed lens well surface. They are used for the storage and chemical disinfection of hard, GP or soft contact lenses. They are not to be used with heat disinfection.

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):	No
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?
16581	Contact lens case	A container, typically made of plastic, designed for the storage of contact lenses when the lenses are not being used by the owner. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRX	Case, Contact Lens

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: 2861bf2f-e913-4562-bd2a-7d80f71fc39c
Public Version Date: March 23, 2021
Public Version Number: 3
DI Record Publish Date: December 08, 2017