AccessGUDID - DEVICE: UVEX (D798SG0)

GUDID

Device Identifier (DI) Information

Brand Name: UVEX
Version or Model: SG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SG
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798SG0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: Uvex Skyper protective eyewear to protect eyes from powerful light sources being used in offices. These glasses can not be used with your prescription eyewear.

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:	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?
30881	Phototherapy eye protector, reusable	A device worn to cover and protect the eyes of a patient or user from potentially harmful rays [e.g., ultraviolet (UV)] to which parts, or all, of their body is intentionally exposed during light therapy treatment. It will typically be designed as goggles, special spectacles, or a mechanical mask-like shield with properties to block or inhibit the transmission of rays to the eyes. It will come in a variety of sizes, e.g., premature infant, neonatal, child, and adult. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Store at ambient conditions.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3d05d1f0-3aed-4536-b4b0-4d2e26e0fda3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 01, 2016