FDA UDI In Commercial Distribution 🇺🇸 United States

Leksell Vantage Stereotactic System

DI: 07340048311595 · Model: 1072931 · Elekta Instrument AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Leksell Vantage Stereotactic System
Primary DI
07340048311595
Version / Model
1072931
Catalog Number
1072931
Company Name
Elekta Instrument AB
Labeler DUNS
507772663
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-09-10
Public Version
2
Public Version Date
2021-11-15
Public Version Status
Update
Public Device Record Key
1d64f47c-5345-4180-a77c-644b702ad730

Device Description

VANTAGE RADIOLUCENT STARBURST 1/2"

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
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HAW Neurological Stereotaxic Instrument

GMDN Terms

Code Name
32568 Neurological stereotactic surgery system

Identifiers

Type ID
Direct Marking 07340048311601
Primary 07340048311595