FDA UDI In Commercial Distribution 🇺🇸 United States

TOPCON

DI: 08034028770319 · Model: CC-100 · VISIA IMAGING SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
TOPCON
Primary DI
08034028770319
Version / Model
CC-100
Catalog Number
120503300
Company Name
VISIA IMAGING SRL
Labeler DUNS
447668039
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-09-15
Public Version
1
Public Version Date
2022-09-23
Public Version Status
New
Public Device Record Key
86514784-0fd7-4e53-a5bf-716b901ebba9

Device Description

instrument intended for use by an optometric/ ophthalmic professional for the analysis of visual acuity

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
Yes
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
HOX Chart, Visual Acuity

GMDN Terms

Code Name
35922 Visual acuity projector

Identifiers

Type ID
Primary 08034028770319