Primary Device ID | B091230120 |
NIH Device Record Key | 7f50614d-c946-4d39-9c6f-4681124d1b5e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Silicone Suction Cup (10pk) |
Version Model Number | 2 |
Catalog Number | 23012 |
Company DUNS | 002373249 |
Company Name | Gulden Ophthalmics Inc. |
Device Count | 10 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B091230120 [Unit of Use] |
HIBCC | B091230122 [Primary] |
KYE | Inserter/Remover Contact Lens |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-09-12 |
Device Publish Date | 2024-09-04 |
B091230120 - Silicone Suction Cup (10pk) | 2024-09-12 |
B091230120 - Silicone Suction Cup (10pk) | 2024-09-12 |
B091141500 - 10mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a pros |
B091141510 - 12mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis. |
B091141520 - 14mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis. |
B091141530 - 16mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis. |
B091141540 - 18mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis. |
B091141550 - 20mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis. |
B091141560 - 22mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis. |