EndoSerter-PL

Primary DI
00855934007485
Brand
EndoSerter-PL
Company
CorneaGen LLC
Model
ES-PL
Device description
The EndoSerter-PL is a sterile, single use, hand held, manual ophthalmic surgical instrument. It is used to pre-load a processed donor corneal endothelial allograft for storage and transportation to the ophthalmic surgeon and to deliver the allograft into the anterior chamber of the eye during corneal surgery. It is designed to deliver a corneal endothelial allograft into the eye during corneal endothelial keratoplasty. The loading and storage of donor tissue for transport to the surgeon can be performed by any trained eye bank technician. Users of this instrument are experienced ophthalmic surgeons in a healthcare facility or hospital. Under no situation will empty EndoSerter-PL units be supplied directly to surgeons for loading.
Published
2023-06-09
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203586000EndoSerter-PLCorneagen, Inc.2022-02-02OTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855934007485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855934007485008559340074858559340074850855934007485

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
00855934007003EndoSerterCorneaGen LLCOTZ2020-11-03