Device
Corneal Trephine Blade Ø 7.0 mm Stainless Steel
Manufacturer
SURTEX INSTRUMENTS LTD.
SURTEX INSTRUMENTS LTD.
Model: OP-400-04
DI: 05055445956196
Status: New
MRI: MR Conditional
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
Corneal Trephine Blade Ø 7.0 mm Stainless Steel
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bec10f35-932e-4348-812e-524d5d77d1a3
Distribution Status:
In Commercial Distribution
DUNS Number:
216232502
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05055445956196
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 32822
Name: Corneal trephine manual instrument
Definition:
A hand-held, ophthalmic surgical instrument, constructed as a one-piece handle with trephine (not an exchangeable component) that is manually rotated with downward pressure by a surgeon in order to cut and remove circular pieces of corneal tissue (corneal buttons). The trephine portion consists of a shaft that has at its working end an extremely sharp, bevelled, cylindrical cutting edge. Healthy tissue may be taken from cadavers for transplant to the recipient, where the defect cornea is cut and removed for acceptance of the replacement. This is a reusable device.
FDA Product Codes
HRH
Trephine, manual, ophthalmic