Symblepharon Ring - 22mm 14346

GUDID B091143460

Symblepharon rings are effective in keeping ocular fornices formed after surgery, in situations where conjunctival cicatricial disease is present, or

Gulden Ophthalmics Inc.

Symblepharon ring, synthetic
Primary Device IDB091143460
NIH Device Record Keyaa9d553d-1309-450a-8811-b847785a4b3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSymblepharon Ring - 22mm
Version Model Number14346
Catalog Number14346
Company DUNS002373249
Company NameGulden Ophthalmics 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

Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com
Phone1-800-659-2200
Emailadmin@guldenophthalmics.com

Device Dimensions

Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB091143460 [Primary]

FDA Product Code

HQNConformer, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


[B091143460]

Hydrogen Peroxide;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

Devices Manufactured by Gulden Ophthalmics Inc.

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B091141550 - 20mm Eye Sphere (non-sterile)2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
B091141560 - 22mm Eye Sphere (non-sterile)2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.

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