| Primary Device ID | D867CLCMLP051 |
| NIH Device Record Key | b09177b5-5b47-4b2b-888e-9a701c767e7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cusp-Lok |
| Version Model Number | CMLP |
| Catalog Number | CLCM05LP |
| Company DUNS | 804495695 |
| Company Name | Xemax Surgical Products Inc |
| Device Count | 5 |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | D867CLCMLP05 [Primary] |
| HIBCC | D867CLCMLP051 [Unit of Use] |
| EJF | Bracket, Metal, Orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
[D867CLCMLP051]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-19 |
| Device Publish Date | 2022-09-09 |
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| D867CLIMLP051 | Orthodontic bracket with chain |
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| D867CLIMCLP051 | Orthodontic bracket with chain |
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| D867CLILP51 | Orthodontic bracket with chain |
| D867CLIIMLP101 | Orthodontic bracket with chain |
| D867CLIIMLP051 | Orthodontic bracket with chain |
| D867CLIIMCLP101 | Orthodontic bracket with chain |
| D867CLIIMCLP051 | Orthodontic bracket with chain |
| D867CLIIMC101 | Orthodontic bracket with chain |
| D867CLIIM101 | Orthodontic bracket with chain |
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| D867CLIILP051 | Orthodontic bracket with chain |
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