| Primary Device ID | D68310952305 |
| NIH Device Record Key | 7f5d9a6a-71f9-4205-9e45-323fcae8a4b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PerfectPearl Midnight |
| Version Model Number | 10-9523 |
| Company DUNS | 145963778 |
| Company Name | METREX RESEARCH, LLC |
| Device Count | 200 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +18008411428 |
| customercare@kavokerrgroup.com | |
| Phone | +18008411428 |
| customercare@kavokerrgroup.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00615375004111 [Primary] |
| GS1 | 00615375007129 [Unit of Use] |
| HIBCC | D68310952305 [Secondary] |
| EHL | POINT, ABRASIVE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-31 |
| D68310952305 | Disposable Prophy Contra Angles Black Shell Teal Pad Soft Cup |
| D68310952204 | Disposable Prophy Contra Angles Black Shell Pink Pad Soft Cup |
| D68310952103 | Disposable Prophy Contra Angles Black Shell Purple Pad Soft Cup |
| D6831095190 | Disposable Prophy Contra Angles Black Shell Teal Pad Standard Cup |
| D68310951809 | Disposable Prophy Contra Angles Black Shell Pink Pad Standard Cup |
| D68310951708 | Disposable Prophy Contra Angles Black Shell Purple Pad Standard Cup |