EndoSerter-PL

GUDID 00855934007485

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.

CORNEAGEN INC.

Donor cornea delivery set

• Primary Device ID: 00855934007485
• NIH Device Record Key: 849bf5cb-c22d-4c89-9b5c-d7316c294144
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoSerter-PL
• Version Model Number: ES-PL
• Company DUNS: 116934664
• Company Name: CORNEAGEN INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855934007485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203586

FDA Product Code

• OTZ: Graft Insertion Instrument For Endothelial Keratoplasty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09