AccessGUDID - DEVICE: SynergEyes casted button (A50009)

GUDID

Device Identifier (DI) Information

Brand Name: SynergEyes casted button
Version or Model: petrafocon A hem-larafilcon A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYNERGEYES, INC.

Primary DI Number: A50009
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 363381182 *Terms of Use

Device Description: SynergEyes petrafocon A hem-larafilcon A casted button

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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?
47840	Rigid-gas-permeable corrective contact lens, daily-wear	A rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. 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. The lens may last for years and is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQD	Lens, Contact (Other Material) - Daily

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083921	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: 292717be-6b36-4546-a254-1b3f9ecc0214
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 14, 2017