Device
This device is a manual instrument and used in general surgery. It is intended for magnifying the surgical area for the surgeon during the operation. It is widely used in dentistry...
Manufacturer
Changzhou Sifary Medical Technology Co., Ltd.
Changzhou Sifary Medical Technology Co., Ltd.
Model: ibT3040T
Catalog: 5080980
DI: 06941877825188
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
This device is a manual instrument and used in general surgery. It is intended for magnifying the surgical area for the surgeon during the operation. It is widely used in dentistry, ENT and other general surgery.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ab76edc2-cf1d-4fcc-9099-70cd200d77c4
Distribution Status:
In Commercial Distribution
DUNS Number:
560366787
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06941877825188
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 32692
Name: Surgical binoculars, reusable
Definition:
A pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.
FDA Product Codes
FSP
Loupe, Diagnostic/Surgical