AccessGUDID - DEVICE: Top Care Contact Lens Case (00036800296695)

GUDID

Device Identifier (DI) Information

Brand Name: Top Care Contact Lens Case
Version or Model: C283TC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 003680029669
Company Name: Topco Associates, LLC

Primary DI Number: 00036800296695
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 072943876 *Terms of Use

Device Description: Contact Lens Case intended for storage of soft (hydrophilic), rigid gas permeable or hard contact lenses during chemical disinfection. Not to be used during 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):	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?
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: 40ba7f0a-d544-49b0-8fa3-3e8053242772
Public Version Date: September 18, 2024
Public Version Number: 4
DI Record Publish Date: August 05, 2016