Duns Number:257382580
Device Description: The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The r 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).
Catalog Number
-
Brand Name
Symblepharon Ring Conformer Medium, In Bulk
Version/Model Number
21-414V
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 24, 2022
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQN
Product Code Name
Conformer, Ophthalmic
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 192 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |