Primary Device ID | 00850003069616 |
NIH Device Record Key | b881208d-e8c7-406a-8709-03ef278de408 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AIT-250R |
Version Model Number | 25042-11-002 |
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 | 00850003069616 [Primary] |
HRJ | Table, Instrument, Powered, Ophthalmic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-25 |
Device Publish Date | 2025-07-17 |
00850053428708 - OC-2200 | 2025-09-26 OC-2200 CHAIR AUTUMN LEAF 110V HIGH; Ophthalmic examination chair |
00850053428715 - OC-2200 | 2025-09-26 OC-2200 CHAIR AUTUMN LEAF 110V LOW; Ophthalmic examination chair |
00850053428722 - OC-2200 | 2025-09-26 OC-2200 CHAIR AUTUMN LEAF 220V HIGH; Ophthalmic examination chair |
00850053428739 - OC-2200 | 2025-09-26 OC-2200 CHAIR AUTUMN LEAF 220V LOW; Ophthalmic examination chair |
00850053428647 - OC-2300 | 2025-09-11 OC-2300 CHAIR WHITE 120 VOLT LOW; Ophthalmic examination chair |
00850053428654 - OC-2300 | 2025-09-11 OC-2300 CHAIR WHITE 120 VOLT HIGH; Ophthalmic examination chair |
00850053428661 - OC-2200 | 2025-09-11 OC-2200 CHAIR WHITE 120 VOLT LOW; Ophthalmic examination chair |
00850053428678 - OC-2200 | 2025-09-11 OC-2200 CHAIR WHITE 120 VOLT HIGH; Ophthalmic examination chair |