FDA UDI In Commercial Distribution 🇺🇸 United States

Horizon 3.0 230V US Mains Filter

DI: 05060229532671 · Model: 5632-00 · THE MAGSTIM COMPANY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Horizon 3.0 230V US Mains Filter
Primary DI
05060229532671
Version / Model
5632-00
Company Name
THE MAGSTIM COMPANY LIMITED
Labeler DUNS
500375274
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-12-21
Public Version
1
Public Version Date
2021-12-29
Public Version Status
New
Public Device Record Key
3c296043-847e-4d8c-a61a-9187cc579121

Device Characteristics

Single Use
No
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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OBP Transcranial Magnetic Stimulator

GMDN Terms

Code Name
61124 Magnetic neural stimulation system

Identifiers

Type ID
Primary 05060229532671

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K211389 000