AccessGUDID - DEVICE: Symblepharon Ring Conformer Medium, In Bulk (M87221414V93)

GUDID

Device Identifier (DI) Information

Brand Name: Symblepharon Ring Conformer Medium, In Bulk
Version or Model: 21-414V
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Oculo-Plastik Inc

Primary DI Number: M87221414V93
Issuing Agency: HIBCC
Commercial Distribution End Date: March 24, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 257382580 *Terms of Use

Device Description: The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is inserted between the eye and the lid and is supported by the sclera without touching the cornea. The purpose of the Symblepharon Rings is to avoid tissue adhesion after excision of the symblepharon. The ring has a center hole to enable the patient to see. The surfaces are polished in order to avoid any abrasion of the cornea or ocular globe. The Symblepharon Rings are medical devices made of acrylic (PMMA). They must not be autoclaved, otherwise they will be damaged: ethylene oxide sterilization is recommended. The devices' family has different sizes (small, medium, large).

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: 22 Millimeter

Device Record Status

Public Device Record Key: 9c4211ef-f1f5-44ec-a557-5957db948680
Public Version Date: March 25, 2022
Public Version Number: 3
DI Record Publish Date: October 16, 2016