AccessGUDID - DEVICE: EQUATE (06971531016393)

GUDID

Device Identifier (DI) Information

Brand Name: EQUATE
Version or Model: WU-102003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WAL-MART STORES, INC.

Primary DI Number: 06971531016393
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 051957769 *Terms of Use

Device Description: CONTACT LENS CASES 12 PACK FOR STORAGE OF SOFT, HARD, AND RIGID GAS PERMEABLE CONTACT LENSES DURING CHEMIAL DISINFECTION. USE FOR STORAGE DURING CHEMICAL DISINFECTINS ONLY. DO NOT USE 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:	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?
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
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172925	000

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: d34fb565-01b4-4aa5-890c-527d15b0abf9
Public Version Date: October 22, 2018
Public Version Number: 2
DI Record Publish Date: March 15, 2018