Gulden Ophthalmics Inc.

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

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- Catalog Number : 13107

Device Description : Manual Tonometer is used to gauge the internal pressure of the eye using weights Manual Tonometer is used to gauge the internal pressure of the eye using weights and a tonometer tip.

Device Class : 2

Duns Number: 002373249

Premarket Exempt : No

Product Code : HKY

Prescription Use : No

Device Count : 1

- Catalog Number : 13110

Device Description : Manual tonometer used to gauge internal pressure within the eye. An allen wrench Manual tonometer used to gauge internal pressure within the eye. An allen wrench can be used to adjust weight settings.

Device Class : 2

Duns Number: 002373249

Premarket Exempt : No

Product Code : HKY

Prescription Use : No

Device Count : 1

- Catalog Number : 14150

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

Device Class :

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 12

- Catalog Number : 14151

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

Device Class :

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 12

- Catalog Number : 14152

Device Description : Eye Sphere is implanted to fill the eye sac during evisceration or enucleation t Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.

Device Class :

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 12

- Catalog Number : 14153

Device Description : Eye Sphere is implanted to fill the eye sac during evisceration or enucleation t Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.

Device Class :

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 12

- Catalog Number : 14154

Device Description : Eye Sphere is implanted to fill the eye sac during evisceration or enucleation t Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.

Device Class :

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 12

- Catalog Number : 14155

Device Description : Eye Sphere is implanted to fill the eye sac during evisceration or enucleation t Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.

Device Class :

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 12

- Catalog Number : 14156

Device Description : Eye Sphere is implanted to fill the eye sac during evisceration or enucleation t Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.

Device Class :

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HPZ

Prescription Use : Yes

Device Count : 12

- Catalog Number : 14164

Device Description : Conformer is temporarily implanted between the eye ball and the eye lid to prote Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it.

Device Class :

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HQN

Prescription Use : Yes

Device Count : 100