AccessGUDID - DEVICE: Raindrop Near Vision Inlay (10850394006013)

GUDID

Device Identifier (DI) Information

Brand Name: Raindrop Near Vision Inlay
Version or Model: RD1-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RD1-1
Company Name: REVISION OPTICS, INC.

Primary DI Number: 10850394006013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015504442 *Terms of Use

Device Description: The Raindrop Near Vision Inlay is a biocompatible hydrogel corneal inlay. It is designed to be implanted under a femtosecond laser flap onto the stromal bed of the cornea, centered over a light-constricted pupil. The Raindrop Near Vision Inlay reshapes the central region of the cornea to provide a zone of increased power for focusing on near objects, resulting in improvement in near vision. The Raindrop Near Vision Inlay is supplied steam sterilized and pre-loaded in its delivery device, the Inlay Inserter. It is for single-use only.

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?
47959	Corneal inlay, aperture reducing	A sterile implantable device inserted into the natural cornea to treat presbyopia [age-related hyperopia (far sightedness)] based on aperture reduction. It is typically made of plastic material and is shaped as a thin annulus (disc) formed to fit the curvature of the cornea; it includes a central opening that restricts the optical aperture of the eye to increase depth of field. It is intended for long-term implantation and is surgically inserted in an intrastromal pocket or flap made by a keratome or an appropriate laser.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LQE	Implant, Corneal, Refractive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150034	000

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
Handling Environment Temperature: between 5 and 55 Degrees Celsius
Storage Environment Temperature: between 5 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter

Device Record Status

Public Device Record Key: 33d476cf-aece-4eb2-bd38-0b6109153394
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 19, 2016