Symblepharon Ring Conformer Large

GUDID M8722141608

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).

Oculo-Plastik Inc

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Primary Device IDM8722141608
NIH Device Record Keyb22100bb-5e2c-4b03-a7d3-c144e4be2e34
Commercial Distribution Discontinuation2022-03-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSymblepharon Ring Conformer Large
Version Model Number21-416
Company DUNS257382580
Company NameOculo-Plastik Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com

Device Dimensions

Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter
Outer Diameter24 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM8722141608 [Primary]

FDA Product Code

HQNConformer, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

[M8722141608]

Hydrogen Peroxide;Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-03-25
Device Publish Date2016-10-16

On-Brand Devices [Symblepharon Ring Conformer Large]

10697660002382The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is
M8722141608The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is
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