AccessGUDID - DEVICE: Symblepharon Ring

GUDID

Device Identifier (DI) Information

Brand Name: Symblepharon Ring - 20mm
Version or Model: 14345
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 14345
Company Name: Gulden Ophthalmics Inc.

Primary DI Number: B091143450
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: Symblepharon rings are used in order to keep ocular fornices formed after surgery, in situations where conjunctival cicatricial disease is present, or after ocular trauma such as chemical burns or avulsion of the conjunctiva. The ring prevent adhesions and shortening or retraction of the fornices and cul-de-sacs without touching the cornea.

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?
16073	Symblepharon ring, synthetic	An implantable device formed as a circular band used to help prevent the eyelid from adhering to the eyeball. It is used occasionally in the case of, e.g., glaucoma, to keep raw surfaces separated. The device is made of synthetic material, e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, a polymer, or copolymer material.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HQN	Conformer, Ophthalmic

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 [?]
Hydrogen Peroxide
Ethylene Oxide

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: b0d1f12e-fb54-4269-94c3-386e0d2f7cbf
Public Version Date: July 03, 2023
Public Version Number: 3
DI Record Publish Date: September 23, 2016