FDA UDI In Commercial Distribution 🇺🇸 United States

AIT-W1

DI: 00852683007261 · Model: 25047-11-000 · TOPCON MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AIT-W1
Primary DI
00852683007261
Version / Model
25047-11-000
Company Name
TOPCON MEDICAL SYSTEMS, INC.
Labeler DUNS
053547238
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-07
Public Version
2
Public Version Date
2023-05-25
Public Version Status
Update
Public Device Record Key
fd65e87f-6117-4990-96e9-a29513a692a8

Device Description

AIT-W1 Adjustable Table 120 Volt; AC-Powered Ophthalmic Instrument Table

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
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
HRJ Table, Instrument, Powered, Ophthalmic

GMDN Terms

Code Name
36400 Ophthalmic instrument table, line-powered

Identifiers

Type ID
Primary 00852683007261