| Primary Device ID | D68310951304 |
| NIH Device Record Key | 8e358163-ee95-4a28-8d98-ad6d7e7d4335 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PerfectPearl Classic |
| Version Model Number | 10-9513 |
| 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 | 00615375004029 [Primary] |
| GS1 | 00615375007037 [Unit of Use] |
| HIBCC | D68310951304 [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 |
| D68310951607 | Disposable Prophy Contra Angles Blue Shell Purple Pad Soft Cup |
| D68310951506 | Disposable Prophy Contra Angles Blue Shell Pink Pad Soft Cup |
| D68310951405 | Disposable Prophy Contra Angles Blue Shell Dark Blue Pad Soft Cup |
| D68310951304 | Disposable Prophy Contra Angles Blue Shell Purple Pad Standard Cup |
| D68310951203 | Disposable Prophy Contra Angles Blue Shell Pink Pad Standard Cup |
| H658890045881 | Disposable Prophy Contra Angles Blue Shell Dark Blue Pad Standard Cup |