Symblepharon Ring - 20mm 14345

GUDID B091143450

Symblepharon rings are used in order to keep ocular fornices formed after surgery, in situations where conjunctival cicatricial disease is present, or

Gulden Ophthalmics Inc.

Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic
Primary Device IDB091143450
NIH Device Record Keyb0d1f12e-fb54-4269-94c3-386e0d2f7cbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSymblepharon Ring - 20mm
Version Model Number14345
Catalog Number14345
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 Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB091143450 [Primary]

FDA Product Code

HQNConformer, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

Hydrogen Peroxide;Ethylene Oxide


[B091143450]

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.

B091141500 - 10mm Eye Sphere (non-sterile)2023-07-27 Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a pros
B091141510 - 12mm Eye Sphere (non-sterile)2023-07-27 Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis.
B091141520 - 14mm Eye Sphere (non-sterile)2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
B091141530 - 16mm Eye Sphere (non-sterile)2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
B091141540 - 18mm 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.
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.
B091112000 - Tangent Screen2023-07-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.