AccessGUDID - DEVICE: Vial Assembly (B222900)

GUDID

Device Identifier (DI) Information

Brand Name: Vial Assembly
Version or Model: 900
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Paragon Vision Sciences, Inc.

Primary DI Number: B222900
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 028594987 *Terms of Use

Device Description: Contact lens vial with cap and gasket/claw The finished assemblies can be made with variation in the color of the cap and the insertion of a gasket or a claw. Additionally, the claw has three distinct sizes, Small (S), Large (L), and Extra Large (X).

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: 97ac2c69-18c6-4c08-9827-8a56dc50ef21
Public Version Date: March 23, 2021
Public Version Number: 3
DI Record Publish Date: December 08, 2017