10mm Eye Sphere (non-sterile) 14150

GUDID B091141500

Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.

Gulden Ophthalmics Inc.

Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant
Primary Device IDB091141500
NIH Device Record Key1ccece34-53e6-4d58-8aff-5795ce09fa70
Commercial Distribution StatusIn Commercial Distribution
Brand Name10mm Eye Sphere (non-sterile)
Version Model Number14150
Catalog Number14150
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

Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com
Phone215-659-2250
Emailadmin@guldenophthalmics.com

Device Dimensions

Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB091141500 [Primary]

FDA Product Code

HPZImplant, Eye Sphere

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-27
Device Publish Date2023-07-19

On-Brand Devices [10mm Eye Sphere (non-sterile)]

B091141501Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surger
B091141500Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surger
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.