| Primary Device ID | 14589864500145 |
| NIH Device Record Key | 374e9de1-eee2-4c57-ada3-57c8a943c99a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPELAIII Attached Belt (M-L) |
| Version Model Number | -H |
| Company DUNS | 696055151 |
| Company Name | TAIYO CORPORATION |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14589864500145 [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 | 2020-12-16 |
| Device Publish Date | 2020-12-08 |
| 14589864500282 - OPELAIII Protected Special Package | 2022-07-15 Wearable Surgical Lighting System |
| 14589864500336 - OPELAIII COOLMAX® Comfort Inner Pads | 2022-07-15 Wearable Surgical Lighting System |
| 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) | 2020-12-16Wearable Surgical Lighting System |
| 14589864500145 - OPELAIII Attached Belt (M-L) | 2020-12-16 Wearable Surgical Lighting System |