EndoSerter

Primary DI
00855934007003
Brand
EndoSerter
Company
CorneaGen LLC
Model
ES-1
Catalog number
ES-1
Device description
The EndoSerter Corneal Endothelium Delivery Instrument is a device used for delivering a corneal endothelial allograft into the eye. The EndoSerter consists of the instrument’s body and its internal mechanism and carrier. The EndoSerter is a sterile, disposable, single-use only device. When loaded with allograft tissue, rotated, and inserted into the eye the allograft can be deployed in the anterior chamber.
Published
2020-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OTZGraft Insertion Instrument For Endothelial Keratoplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTZGraft Insertion Instrument For Endothelial KeratoplastyOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855934007003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855934007003008559340070038559340070030855934007003

GMDN Terms#

Term, Definition table
TermDefinition
Donor cornea delivery setA collection of sterile devices designed to hold and deliver prepared donor endothelial tissue for transplantation into a recipient eye following the removal of Descemet's membrane and dysfunctional endothelium from the patient's cornea during ophthalmic surgery. It typically consists of a preparation base, a cartridge which holds the tissue in a double-coil preventing the surfaces/edges from folding and touching, and an introducer to manually position the cartridge from where the tissue is glided into the eye in correct orientation to unfold. This set is only used for partial replacement of dysfunctional corneal cell layers and not for total cornea replacement. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080423639
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855934007010CoronetSLS-10-6502024-06-14
00855934007027CoronetSLS-10-6752024-06-14
00855934007034CoronetSLS-10-7002024-06-14
00855934007041CoronetSLS-10-7252024-06-14
00855934007058CoronetSLS-10-7502024-06-14
00855934007065CoronetSLS-10-7752024-06-14
00855934007072CoronetSLS-10-8002024-06-14
00855934007089CoronetSLS-10-8252024-06-14
00855934007096CoronetSLS-10-8502024-06-14
00855934007102CoronetSLS-10-8752024-06-14
00855934007119CoronetSLS-10-9002024-06-14
00855934007126CoronetSLS-10-9502024-06-14
00855934007133CoronetSLS-20-6002024-06-14
00855934007140CoronetSLS-20-6252024-06-14
00855934007157CoronetSLS-20-6502024-06-14
00855934007164CoronetSLS-20-6752024-06-14
00855934007171CoronetSLS-20-7002024-06-14
00855934007188CoronetSLS-20-7252024-06-14
00855934007195CoronetSLS-20-7502024-06-14
00855934007201CoronetSLS-20-7752024-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010356203Fischer-USAFischer Surgical, Inc.OTZ2023-10-13
00855934007485EndoSerter-PLCorneaGen LLCOTZ2023-06-09