guldenophthalmics.comEYE SPHERE, CONFORMERS
GULDEN OPHTHALMICS
GULDEN OPHTHALMICS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2518410 | 2518410 | GULDEN OPHTHALMICS | 1 | N | 2026-01-01 | 225 CADWALADER AVE. Elkins Park PA US 19027 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B091141520 | 14mm Eye Sphere (non-sterile) - Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis. | 1-800-659-2250 | admin@guldenophthalmics.com |
| B091141530 | 16mm Eye Sphere (non-sterile) - Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis. | 1-800-659-2250 | admin@guldenophthalmics.com |
| B091141540 | 18mm Eye Sphere (non-sterile) - Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis. | 1-800-659-2250 | admin@guldenophthalmics.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 72383 | 1155843908 | K972661 | EYE SPHERE, CONFORMERS | HPZ | 1997-10-03 |
| 72383 | 1058978454 | ||||
| 72383 | 1177803320 | ||||
| 72383 | 1343398661 | ||||
| 72383 | 1775473686 | ||||
| 72383 | 1792569721 | ||||
| 72383 | 1829740027 | ||||
| 72383 | 1905278022 | ||||
| 72383 | 1965384050 | ||||
| 72383 | 1009351755 | ||||
| 72383 | 1019090197 | ||||
| 72383 | 1060478622 | ||||
| 72383 | 1069242289 | ||||
| 72383 | 1084339624 | ||||
| 72383 | 1136687441 | ||||
| 72383 | 1142745318 | ||||
| 72383 | 1238860761 | ||||
| 72383 | 1326178930 | ||||
| 72383 | 1336652084 | ||||
| 72383 | 1348418739 | ||||
| 72383 | 1353618810 | ||||
| 72383 | 1360125450 | ||||
| 72383 | 1391060819 | ||||
| 72383 | 1484079674 | ||||
| 72383 | 1508637875 | ||||
| 72383 | 1531867526 | ||||
| 72383 | 1571961955 | ||||
| 72383 | 1574018147 | ||||
| 72383 | 1582698767 | ||||
| 72383 | 1589155282 | ||||
| 72383 | 1717814638 | ||||
| 72383 | 1757140975 | ||||
| 72383 | 1784288494 | ||||
| 72383 | 1784447231 | ||||
| 72383 | 1792967934 | ||||
| 72383 | 1806876497 | ||||
| 72383 | 1808841896 | ||||
| 72383 | 1810106819 | ||||
| 72383 | 1902049976 | ||||
| 72383 | 1938886701 | ||||
| 72383 | 2009573286 | ||||
| 72383 | 2023086186 | ||||
| 72383 | 2045418855 | ||||
| 72383 | 2066474001 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HPZ | 2 | 1997-10-03 |
PMN#
GUDID#
Silicone Suction Cup (10pk) - 2
2024-09-04
Silicone Suction Cup (10pk) - 2
2024-09-04
Silicone Suction Cup (12 pk) - 1
2023-07-05
22mm Eye Sphere (non-sterile) - Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
2023-07-19
20mm Eye Sphere (non-sterile) - Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
2023-07-19
18mm Eye Sphere (non-sterile) - Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
2023-07-19
16mm Eye Sphere (non-sterile) - Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
2023-07-19
14mm Eye Sphere (non-sterile) - Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
2023-07-19
12mm Eye Sphere (non-sterile) - Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis.
2023-07-19
10mm Eye Sphere (non-sterile) - Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.
2023-07-19
Flashing Fixation Sticks (2pk) - 1
2023-07-05
Opto Clip (2 pk) - 1
2023-07-05
Face Fixation Sticks (3pk) - 1
2023-07-05
Pediatric Fixation Sticks (3pk) - 1
2023-07-05
Fixation Sticks (4pk) - 1
2023-07-05
Pediatric Fixation Wand - 1
2023-07-05
Flashing Butterfly Fixation Stick - 1
2023-07-05
Color Fixation Sticks - 1
2023-07-05
Retinoscopy Rack - 1
2023-07-05
Retinoscopy Rack with Compass - 1
2023-07-05
Brock String - 1
2023-07-05
Peds Pack - 1
2023-07-05
Clip-on Spielmann - 1
2023-07-05
Clip-on Occluder - 1
2023-07-05
Clip-on Multiple Pinhole Occluder - 1
2023-07-05
Tangent Screen - 1
2023-07-05
Silicone Eye Sphere - 22mm - Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
2016-09-23
Silicone Eye Sphere - 20mm - Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
2016-09-23
Silicone Eye Sphere - 18mm - Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
2016-09-23
Silicone Eye Sphere - 16mm - Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
2016-09-23
Silicone Eye Sphere - 14mm - Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
2016-09-23
Silicone Eye Sphere - 12mm - Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
2016-09-23
Symblepharon Ring - 24mm - Symblepharon rings are effective in keeping ocular fornices formed after surgery, in situations where conjunctival cicatricial disease is present, or after ocular trauma such as chemical burns or avulsion of the conjunctiva. The ring prevent adhesions and shortening or retraction of the fornices and cul-de-sacs without touching the cornea.
2016-09-23
Symblepharon Ring - 22mm - Symblepharon rings are effective in keeping ocular fornices formed after surgery, in situations where conjunctival cicatricial disease is present, or after ocular trauma such as chemical burns or avulsion of the conjunctiva. The ring prevent adhesions and shortening or retraction of the fornices and cul-de-sacs without touching the cornea.
2016-09-23
Symblepharon Ring - 20mm - Symblepharon rings are used in order to keep ocular fornices formed after surgery, in situations where conjunctival cicatricial disease is present, or after ocular trauma such as chemical burns or avulsion of the conjunctiva. The ring prevent adhesions and shortening or retraction of the fornices and cul-de-sacs without touching the cornea.
2016-09-23
Schioetz Tonometer - Allen Wrench Modification - Manual tonometer used to gauge internal pressure within the eye. An allen wrench can be used to adjust weight settings.
2016-09-23
Schioetz Tonometer - Manual Tonometer is used to gauge the internal pressure of the eye using weights and a tonometer tip.
2016-09-23
Dix Magnetic Foreign Body Remover - 1
2022-11-28
Ellis Magnetic Foreign Body Remover - 1
2022-11-28
Luedde Exophthalmometer - 1
2022-11-28