FDA UDI In Commercial Distribution 🇺🇸 United States

Guidance controller

DI: 00854763006041 · Model: 5100 · HALT MEDICAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Guidance controller
Primary DI
00854763006041
Version / Model
5100
Catalog Number
5100
Company Name
HALT MEDICAL, INC
Labeler DUNS
602783495
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-19
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
67cc1b73-d7f4-472f-a0a3-4987140237cb

Device Description

Guidance magnetic tracking controller

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
HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

GMDN Terms

Code Name
57972 Radio-frequency ablation system

Identifiers

Type ID
Primary 00854763006041