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IMPLANT, EYE SPHERE
 Request for Information Form |
 Contact Information
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| Company Name | GULDEN OPHTHALMICS |
| Address | 225 CADWALADER AVE. |
| City, State, Zip | ELKINS PARK, PA 19027 |
| Country | US |
| FDA Owner/Operator Phone | 215-884-8105 201 |
| FDA Medical Specialty Code | OP - Opthalmic |
| FDA Product Code | HPZ |
| FDA Classification Name | IMPLANT, EYE SPHERE |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 886.3320 |
| FDA Common Generic Name | VARIOUS |
| FDA Proprietary Device Name | IMPLANT, EYE SPHERE |
| FDA Owner / Operator Number | 2518410 |
| FDA Owner / Operator Name | GULDEN OPHTHALMICS |
| FDA Establishment Registration Number | 2518410 |
| FDA Registered Establishment Name | GULDEN OPHTHALMICS |
| FDA Operation Code(s) |
MM - Manufacturer MS - Specification Developer |
| FDA Listing Date | 05-22-97 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of GULDEN OPHTHALMICS
Our records indicate that the following medical device companies may manufacture a similar device.| Company Name / Address / Phone | Proprietary Device Name | Common Generic Device Name | |
| 1 | BAUSCH & LOMB, INC. 1501 GRAVES MILL RD. LYNCHBURG, VA 24502 US 585-338-6000 / 585-338-8731 |
VARIOUS EYE SPHERES | VARIOUS EYE SPHERES |
| 2 | BAUSCH & LOMB, INC. 499 SOVEREIGN CT. MANCHESTER, MO 63011 US 585-338-6000 / 585-338-8731 |
MULTIPLE | EYE SPHERE IMPLANT |
| 3 | EVERA MEDICAL, INC. 353 VINTAGE PARK DRIVE SUITE F FOSTER CITY, CA 94404 US 650-287-2884 / 650-525-9750 |
VERAFIL AUGMENTATION IMPLANT | STERILE AUGMENTATION IMPLANT |
| 4 | FCI OPHTHALMICS, INC. 20 WINTER ST PEMBROKE, MA 02359 US 0- 36-412203333 / 508-771-6777 |
ENUCLEATION / EVISCERATION IMPLANTS | ENUCLEATION / EVISCERATION IMPLANTS |
| 5 | FCI PRODUCTION 4, CHEMIN DE PALENTS BESANCON, 25000 FR 0- 36-412203333 / 508-771-6777 |
ENUCLEATION/EVISCERATION IMPLANTS (VARIOUS SIZES) | ENUCLEATION/EVISCERATION IMPLANTS |
| 6 | INTEGRATED ORBITAL IMPLANTS, INC. 12625 HIGH BLUFF DR., #314 SAN DIEGO, CA 92130 US 858-259-4355 / 858-259-4355 |
NO PROPRIETARY NAME LISTED | IMPLANT, EYE SPHERE |
| 7 | JARDON EYE PROSTHETICS, INC. 15920 W. 12 MILE ROAD SOUTHFIELD, MI 48076 US 248-424-8560 / 248-424-8560 |
SPHERE IMPLANT | SILICONE SPHERE IMPLANT |
| 8 | JOHN J. KELLEY ASSOCIATES LTD. 117 SOUTH 17TH ST., SUITE 1902 PHILADELPHIA, PA 19103 US 215-567-1377 / 215-567-1377 |
SPHERE IMPLANT (ACRYLIC) | "MULL SPHERE IMPLANT" (NON-STERILE) |
| 9 | KATENA PRODUCTS, INC. 4 STEWART CT. DENVILLE, NJ 07834 US 973-989-1600 / 973-989-1600 |
SPHERE, EYE | |
| 10 | KHOSLA SURGICAL INDUSTRIES SUDESH BLDG., KENNEDY BRIDGE, NANA CHOWK BOMBAY, 400007 IN 38-75-268269 / 415-651-4041 |
EYE SPHERE | EYE SPHERE |
| 11 | OCULO PLASTIK, INC. 200 SAUVE WEST MONTREAL, QC, H3L 1Y9 CA 514-381-1849 / 514-381-3292 |
NEWQ ALLEN OCULAR IMPLANT | NEW ALLEN PLANT |
| 12 | POREX SURGICAL, INC. 15 DART RD. NEWNAN, GA 30265 US 770-964-1421 / 678-479-1610 602 |
SILICAONE EYE SPHERE IMPLANTS | EYE SPHERE IMPLANTS |
| 13 | W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. FLAGSTAFF, AZ 86003 US 302-738-4880 / 928-864-4736 |
GORE SPHEREX IMPLANT | EYE SPHERE IMPLANT |
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