| Primary Device ID | 06970617030100 |
| NIH Device Record Key | 116a7fdd-f13b-42be-8604-f4d93126a520 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prosthesis, Hawley Retainer, Palatal Expander, Spa |
| Version Model Number | Not Applicable |
| Company DUNS | 526027843 |
| Company Name | SHENZHEN MINGHAO DENTURES 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970617030100 [Primary] |
| NSR | Prosthesis, Orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06970617030100]
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[06970617030100]
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[06970617030100]
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[06970617030100]
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[06970617030100]
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[06970617030100]
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[06970617030100]
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[06970617030100]
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[06970617030100]
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[06970617030100]
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| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-14 |