FDA UDI In Commercial Distribution 🇺🇸 United States

AxiEM™

DI: 00763000738419 · Model: 9734887 · MEDTRONIC NAVIGATION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
AxiEM™
Primary DI
00763000738419
Version / Model
9734887
Company Name
MEDTRONIC NAVIGATION, INC.
Labeler DUNS
835233107
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-03-30
Public Version
1
Public Version Date
2025-04-07
Public Version Status
New
Public Device Record Key
26d5a595-02ef-4a7c-809e-5dce542493c9

Device Description

TRACKER 9734887 NON-INVASIVE PATIENT

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Conditional
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HAW Neurological stereotaxic Instrument

GMDN Terms

Code Name
32568 Neurological stereotactic surgery system

Identifiers

Type ID
Primary 00763000738419

Customer Contacts