Device
STERILE, NEUROMONITORING DILATOR KIT
Manufacturer
TEDAN SURGICAL INNOVATIONS, L.L.C.
TEDAN SURGICAL INNOVATIONS, L.L.C.
Model: MDT-0459S
DI: 00843059126969
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
STERILE, NEUROMONITORING DILATOR KIT
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8f576319-8de8-4cb9-93a0-8b57ea45357c
Distribution Status:
In Commercial Distribution
DUNS Number:
791619393
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00843059126969
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61089
Name: Nerve-locating system probe, single-use
Definition:
A hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.
FDA Product Codes
None