Silicone Suction Cup (10pk) 23012

GUDID B091230120

Gulden Ophthalmics Inc.

Corneal shield applicator
Primary Device IDB091230120
NIH Device Record Key7f50614d-c946-4d39-9c6f-4681124d1b5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Suction Cup (10pk)
Version Model Number2
Catalog Number23012
Company DUNS002373249
Company NameGulden Ophthalmics Inc.
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB091230120 [Unit of Use]
HIBCCB091230122 [Primary]

FDA Product Code

KYEInserter/Remover Contact Lens

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-12
Device Publish Date2024-09-04

Devices Manufactured by Gulden Ophthalmics Inc.

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.

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