Model: Initial Release
Catalog: MDS10M-01
DI: 00884450392928
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d5cf8dc3-8e88-4754-82df-d7309a4863ce
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10884450392925
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
5
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00884450392928
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00884450392928
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
20884450392922
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
16
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10884450392925
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 58183
Name: Electromagnetic surgical navigation device tracking system
Definition:
An assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/spatial markers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].
FDA Product Codes
NEU
MARKER, RADIOGRAPHIC, IMPLANTABLE
Device Sizes
Item #1 - Size Text:
Needle Length (cm)-10.0 cm
Item #1 - Size Type:
Device Size Text, specify
Item #2 - Size Text:
Gauge-16G
Item #2 - Size Type:
Device Size Text, specify