| Primary Device ID | 06975317660848 |
| NIH Device Record Key | a9a5c77e-cdfc-4c1e-9dc0-dbac949e70ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glamb |
| Version Model Number | ROTH 18 |
| Company DUNS | 550845521 |
| Company Name | Jinhua Glamb Medical Equipment Co., Ltd. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 06975317660848 [Primary] |
| EJF | Bracket, Metal, Orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06975317660848]
Moist Heat or Steam Sterilization
[06975317660848]
Moist Heat or Steam Sterilization
[06975317660848]
Moist Heat or Steam Sterilization
[06975317660848]
Moist Heat or Steam Sterilization
[06975317660848]
Moist Heat or Steam Sterilization
[06975317660848]
Moist Heat or Steam Sterilization
[06975317660848]
Moist Heat or Steam Sterilization
[06975317660848]
Moist Heat or Steam Sterilization
[06975317660848]
Moist Heat or Steam Sterilization
[06975317660848]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-05 |
| Device Publish Date | 2022-11-25 |