Primary Device ID | 14589864500107 |
NIH Device Record Key | 9fb771d6-42da-4a02-a105-2c7e17172995 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OPELAIII Standard Package |
Version Model Number | -H |
Company DUNS | 696055151 |
Company Name | TAIYO CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com | |
Phone | +81354406273 |
info@opela3.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 14589864500107 [Primary] |
HPP | Headlamp, Operating, Battery-Operated |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-12-15 |
Device Publish Date | 2020-12-07 |
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14589864500350 - OPELAIII Attached Belt (3L) | 2022-07-15 Wearable Surgical Lighting System |
14589864500237 - OPELAIII Hard Case | 2021-04-15 Wearable Surgical Lighting System |
14589864500275 - OPELAIII Protected Special Package | 2021-04-15 Wearable Surgical Lighting System |
14589864500312 - OPELAIII calibration kit | 2021-04-15 Wearable Surgical Lighting System |
14589864500138 - OPELAIII Dedicated AC Adapter | 2020-12-16 Wearable Surgical Lighting System |
14589864500145 - OPELAIII Attached Belt (M-L) | 2020-12-16 Wearable Surgical Lighting System |