Gulden Ophthalmics Inc.

Address:225 CADWALADER AVE.,Elkins Park,PA,19027,US

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Premarket Exempt
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- Catalog Number : 14347

Device Description : Symblepharon rings are effective in keeping ocular fornices formed after surgery 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.

Device Class : 2

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HQN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 14351

Device Description : Silicone Eye Sphere is implanted within the eye sac during evisceration or enucl Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.

Device Class : 2

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 14352

Device Description : Silicone Eye Sphere is implanted within the eye sac during evisceration or enucl Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.

Device Class : 2

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 14353

Device Description : Silicone Eye Sphere is implanted within the eye sac during evisceration or enucl Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.

Device Class : 2

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 14354

Device Description : Silicone Eye Sphere is implanted within the eye sac during evisceration or enucl Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.

Device Class : 2

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 14355

Device Description : Silicone Eye Sphere is implanted within the eye sac during evisceration or enucl Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.

Device Class : 2

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 14356

Device Description : Silicone Eye Sphere is implanted within the eye sac during evisceration or enucl Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.

Device Class : 2

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 1