FDA UDI In Commercial Distribution 🇺🇸 United States

SeeNA

DI: 08034028770470 · Model: SeeNA · VISIA IMAGING SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
SeeNA
Primary DI
08034028770470
Version / Model
SeeNA
Catalog Number
SEENA006100
Company Name
VISIA IMAGING SRL
Labeler DUNS
447668039
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-05-26
Public Version
1
Public Version Date
2023-06-05
Public Version Status
New
Public Device Record Key
64eae82e-3bb5-4bd3-b223-c9c087bb9ac8

Device Description

INTEGRATED DEVICE OCULAR BIOMETER AND CORNEAL ANALYZER

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HJO Biomicroscope, Slit-Lamp, Ac-Powered

GMDN Terms

Code Name
45734 Corneal topography system analyser

Identifiers

Type ID
Primary 08034028770470

Premarket Submissions

Submission Number Supplement Number
K160327 000