Device
LRI Diamond Step Knife 6-Facet With Pre-Calibrated Depth Setting of 0.6 mm 12.5 cm - 5" Titanium Handle
Manufacturer
SURTEX INSTRUMENTS LTD.
SURTEX INSTRUMENTS LTD.
Model: OP-300-12
DI: 05056111301388
Status: New
MRI: MR Conditional
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
LRI Diamond Step Knife 6-Facet With Pre-Calibrated Depth Setting of 0.6 mm 12.5 cm - 5" Titanium Handle
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b77ac40f-015f-412e-8882-fd4e4e65acc7
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:
05056111301388
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 32764
Name: Ophthalmic knife, reusable
Definition:
A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. This is a reusable device.
FDA Product Codes
EMF
KNIFE, SURGICAL