Device
Kartz-Barraquer Wire Speculum With Open Blades - Standard Wire Blade Size 15 mm Stainless Steel
Manufacturer
SURTEX INSTRUMENTS LTD.
SURTEX INSTRUMENTS LTD.
Model: OP-030-15
DI: 05055445955175
Status: New
MRI: MR Conditional
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
Kartz-Barraquer Wire Speculum With Open Blades - Standard Wire Blade Size 15 mm Stainless Steel
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5b8b2738-21a1-4bf0-a486-7053eaa77213
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:
05055445955175
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35349
Name: Eyelid speculum, reusable
Definition:
A self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. This is a reusable device.
FDA Product Codes
HNC
Specula, ophthalmic