Recipient Vacuum Trephine
Sharp. Accurate. Strong.
The CorneaGen Recipient Vacuum Trephine* provides premium accuracy and control along with an ultra-sharp blade that allows for a more vertical cut with reduced undercut. Developed using military sighting technology for outstanding positioning and centration, along with all-metal ergonomic finger grips for maximum control, our recipient vacuum trephine is the definition of sharp, accurate, and strong.
*indicated for PK only
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Details & Specifications
About the Recipient Vacuum Trephine
- Ultra-sharp blade allows for a more vertical cut with reduced undercut
- Industry-leading crosshairs designed using military sighting technology enable outstanding positioning and centration
- All metal ergonomic finger grips provide complete control
Intended Use
The CorneaGen Recipient Vacuum Trephine is indicated specifically for performing a full Penetrating Keratoplasty (PK) on the recipient eye, during corneal graft surgery.
Instructions for Use
The instructions for use and suggested surgical technique are supplied in the form of a multi-lingual leaflet with instructions given in diagram form where appropriate. The international symbols used on the packaging are explained in each language. A leaflet is supplied with each product.
Sterilization
Products are sterilized by Ethylene Oxide (EO) according to a validated cycle and the requirements of BS EN ISO 11135- 1:2007, by an approved sterilization sub-contractor, Synergy Health Plc. Doncaster, England. The products have a declared sterile shelf life of five years. Devices are designated for Single Use Only.
Size Options:
All sizes available with or without vacuum.
| Trephine Size (mm) | |||
|---|---|---|---|
| 6.00 | 6.25 | 6.50 | 6.75 |
| 7.00 | 7.25 | 7.50 | 7.75 |
| 8.00 | 8.25 | 8.50 | 8.75 |
| 9.00 | 9.50 | 9.75 | |
Material Specification
| Product Component | Specification |
| Trephine Blade and Cross Hair | Stainless Steel (Blade Depth 1.15mm) |
| Trephine Body and Finger Plates | Aluminum |
| Black Capstan | ABS |
| Tubing | Medical Grade Silicone |
| Syringe | Luer-Lok (5ml capacity) |
| Outer Box/Carton | 500 Micron Printed White Boxboard |
Return Policy
Various circumstances arise that require a customer to return distributed product. For such cases involving any of our products, please find our return policy on our Billing Terms and Conditions.
Reimbursement
If you need assistance with reimbursement of corneal tissue, CorneaGen is pleased to provide its customers with reimbursement and medical claims assistance to help guide you in billing corneal tissue to your local Medicare carrier and other commercial insurance carriers.
Adverse Reaction Reporting
If you have had any complications occur in your recipients, we ask you please file a report with us so that we may comply with EBAA and FDA regulations.
Regulatory Information
CorneaGen’s labs maintain the highest levels of quality through review by the U.S. Food and Drug Administration. For more information, please contact our Quality Assurance and Regulatory Affairs Department at (877) 682-8502.