Primary Device ID | 00850053428678 |
NIH Device Record Key | e2b551e6-0caa-4264-9523-5bc925947a6a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OC-2200 |
Version Model Number | 24046-WH-H1-000 |
Company DUNS | 053547238 |
Company Name | TOPCON HEALTHCARE INC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850053428678 [Primary] |
HME | Chair, Ophthalmic, Ac-Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-09-11 |
Device Publish Date | 2025-09-03 |
00850053428678 | OC-2200 CHAIR WHITE 120 VOLT HIGH; Ophthalmic examination chair |
00850053428661 | OC-2200 CHAIR WHITE 120 VOLT LOW; Ophthalmic examination chair |
00850053428739 | OC-2200 CHAIR AUTUMN LEAF 220V LOW; Ophthalmic examination chair |
00850053428722 | OC-2200 CHAIR AUTUMN LEAF 220V HIGH; Ophthalmic examination chair |
00850053428715 | OC-2200 CHAIR AUTUMN LEAF 110V LOW; Ophthalmic examination chair |
00850053428708 | OC-2200 CHAIR AUTUMN LEAF 110V HIGH; Ophthalmic examination chair |