Baolai
GUDID 16970557950053
Nanning Baolai medical instrument Co.,Ltd
Ultrasonic dental scaling/debridement system| Primary Device ID | 16970557950053 |
| NIH Device Record Key | 3364478b-df3a-40b9-9797-9d61a6ee89cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Baolai |
| Version Model Number | P5L |
| Company DUNS | 544921355 |
| Company Name | Nanning Baolai medical instrument Co.,Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 16970557950053 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140233
FDA Product Code
| ELC | Scaler, Ultrasonic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[16970557950053]
Moist Heat or Steam Sterilization
[16970557950053]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-12 |
On-Brand Devices [Baolai]
Trademark Results [Baolai]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BAOLAI 90246074 not registered Live/Pending |
Qiu, Minmin 2020-10-09 |
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