AccessGUDID - DEVICE: Silicone Eye Sphere

GUDID

Device Identifier (DI) Information

Brand Name: Silicone Eye Sphere - 20mm
Version or Model: 14355
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 14355
Company Name: Gulden Ophthalmics Inc.

Primary DI Number: B091143550
Issuing Agency: HIBCC
Commercial Distribution End Date: June 29, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 002373249 *Terms of Use

Device Description: Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.

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?
46902	Orbital sphere implant	An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HPZ	Implant, Eye Sphere

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 20 Millimeter

Device Record Status

Public Device Record Key: 6f5b0e04-eebd-4daa-9564-e32980ad92c6
Public Version Date: July 03, 2023
Public Version Number: 3
DI Record Publish Date: September 23, 2016