FDA UDI In Commercial Distribution 🇺🇸 United States

OC-2300

DI: 00852683007643 · Model: 24045-LB-L1-000 · TOPCON MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
OC-2300
Primary DI
00852683007643
Version / Model
24045-LB-L1-000
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
cfd23fbf-209d-42ff-b746-91c75aa5e151

Device Description

OC-2300 CHAIR-LUXBLU-120LOW; Ophthalmic examination chair

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
HME Chair, Ophthalmic, Ac-Powered

GMDN Terms

Code Name
15723 Ophthalmic chair, line-powered

Identifiers

Type ID
Primary 00852683007643