Gulden Ophthalmics Inc.

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

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Conformer, Ophthalmic (HQN) (8) Implant, Eye Sphere (HPZ) (2)

Premarket Exempt

No Yes

Clear

20mm Sterile Orbital Implant (PMMA) - B091142550 Catalog Number : 14255

Device Class : 2

Duns Number: 002373249

Premarket Exempt : No

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

22mm Sterile Orbital Implant (PMMA) - B091142560 Catalog Number : 14256

Device Class : 2

Duns Number: 002373249

Premarket Exempt : No

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

Small Sterile Eye Conformer (PMMA) - B091142640 Catalog Number : 14264

Device Class : 2

Duns Number: 002373249

Premarket Exempt : No

Product Code : HQN

Prescription Use : Yes

Device Count : 1

Medium Sterile Eye Conformer (PMMA) - B091142650 Catalog Number : 14265

Device Class : 2

Duns Number: 002373249

Premarket Exempt : No

Product Code : HQN

Prescription Use : Yes

Device Count : 1

Large Sterile Eye Conformer (PMMA) - B091142660 Catalog Number : 14266

Device Class : 2

Duns Number: 002373249

Premarket Exempt : No

Product Code : HQN

Prescription Use : Yes

Device Count : 1

Small Sterile Eye Conformer with Holes (PMMA) - B091142670 Catalog Number : 14267

Device Class : 2

Duns Number: 002373249

Premarket Exempt : No

Product Code : HQN

Prescription Use : Yes

Device Count : 1

Medium Sterile Eye Conformer with Holes (PMMA) - B091142680 Catalog Number : 14268

Device Class : 2

Duns Number: 002373249

Premarket Exempt : No

Product Code : HQN

Prescription Use : Yes

Device Count : 1

Large Sterile Eye Conformer with Holes (PMMA) - B091142690 Catalog Number : 14269

Device Class : 2

Duns Number: 002373249

Premarket Exempt : No

Product Code : HQN

Prescription Use : Yes

Device Count : 1

Symblepharon Ring - 20mm - B091143450 Catalog Number : 14345

Device Description : Symblepharon rings are used in order to keep ocular fornices formed after surger 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.

Device Class : 2

Duns Number: 002373249

Premarket Exempt : Yes

Product Code : HQN

Prescription Use : Yes

Device Count : 1

Symblepharon Ring - 22mm - B091143460 Catalog Number : 14346

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

Previous 1 2 3 4 Next