Product code OTZ

Device name
Graft Insertion Instrument For Endothelial Keratoplasty
Medical specialty
Ophthalmic
Device class
1
Regulation number
886.4300
Review panel
OP
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
A graft insertion device for endothelial keratoplasty is a device intended to be inserted into the eye during surgery to direct the insertion of a corneal graft and be removed after insertion is completed.
Source
FDA openFDA device classification dataset