AccessGUDID - DEVICE: ProOcular Daily Disposable Contact Lens (10816816880470)

GUDID

Device Identifier (DI) Information

Brand Name: ProOcular Daily Disposable Contact Lens
Version or Model: -3.5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CARLSBAD TECHNOLOGY INC.

Primary DI Number: 10816816880470
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2019
Device Count: 30
Labeler D-U-N-S® Number*: 079113545 *Terms of Use

Device Description: ProOcular Daily Disposable Contact Lens Power -3.5

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):	Yes
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?
47841	Soft corrective contact lens, daily-disposable	A soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVN	Lens, Contact, (Disposable)

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
Storage Environment Temperature: between 46 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac7fa53b-8acf-4846-96df-be54c8580d0b
Public Version Date: September 20, 2021
Public Version Number: 3
DI Record Publish Date: October 28, 2016