FDA UDI Not in Commercial Distribution 🇺🇸 United States

VirtuEye V1

DI: EFIAE0114201 · Model: 1 · Fiagon GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VirtuEye V1
Primary DI
EFIAE0114201
Version / Model
1
Catalog Number
E 01 1420
Company Name
Fiagon GmbH
Labeler DUNS
312623008
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-11
Public Version
4
Public Version Date
2023-07-19
Public Version Status
Update
Public Device Record Key
b204f9f1-a4fd-4d07-95d5-788ffd84b6a4
Distribution End Date
2023-07-18

Device Description

Accessory to Fiagon navigation systems. Device for registration.

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
PGW Ear, Nose, And Throat Stereotaxic Instrument

GMDN Terms

Code Name
45198 ENT stereotactic surgery system

Identifiers

Type ID
Primary EFIAE0114201