Primary Device ID | 00628308210107 |
NIH Device Record Key | 1aa90dc8-64ab-46cf-8ca0-52cf4f758df5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | S4 Optik |
Version Model Number | 2500-CB-H |
Company DUNS | 247873511 |
Company Name | Blue.S4 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 | 00628308210107 [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 | 2025-02-28 |
Device Publish Date | 2025-02-20 |
00628308210114 | S4OPTIK Combination Chair & Stand - Model 2500-CB-H-L |
00628308210107 | S4OPTIK Combination Chair & Stand - Model 2500-CB-H |
00628308210084 | S4OPTIK Combination Chair & Stand - Model 2000-CB-H-L |
00628308210077 | S4OPTIK Combination Chair & Stand - Model 2000-CB-H |
00628308210053 | S4OPTIK Ophthalmic Examination Chair - Model 2000-CH-H |
00628308210046 | S4OPTIK Ophthalmic Examination Chair - Model 2500-CH-H |
00628308210022 | S4OPTIK Instrument Stand - MODEL 2000-ST |
00628308210183 | S4OPTIK Ophthalmic Examination Chair - ETILT-CH-H-S4 |