AccessGUDID - DEVICE: Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear (18500071350220)

GUDID

Device Identifier (DI) Information

Brand Name: Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
Version or Model: Emerald Toric
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Euclid Vision Corporation

Primary DI Number: 18500071350220
Issuing Agency: GS1
Commercial Distribution End Date: February 22, 2021
Device Count: 2
Labeler D-U-N-S® Number*: 969263979 *Terms of Use

Device Description: Kit containing 850007135058 (Emerald Toric, oprifocon A, blue) and 850007135065 (Emerald Toric, oprifocon A, green)

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):	Yes
Over the Counter (OTC):	No
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?
47926	Orthokeratology contact lens	A rigid-gas-permeable ophthalmic lens intended to be worn directly against the cornea of the eye for orthokeratology (Ortho-K), a procedure where the lens is worn for several hours, typically each night, to modify the curvature of the cornea as an alternative method to correct refractive vision conditions. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUU	Lens, Contact, Orthokeratology, Overnight

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: 703e39ce-6da0-48ee-9a0d-c5e06febe6fd
Public Version Date: April 11, 2023
Public Version Number: 5
DI Record Publish Date: March 02, 2020