| Primary Device ID | 03700512968191 |
| NIH Device Record Key | 47867af5-6767-4924-8c46-0b1733094b9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OlyPercX PCNL Basket |
| Version Model Number | ROKP1001ST245 |
| Catalog Number | RFPERKX |
| Company DUNS | 401020409 |
| Company Name | Promepla |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700512968191 [Primary] |
| GS1 | 03700512978190 [Package] Package: Box 1 [1 Units] In Commercial Distribution |
| GS1 | 03700512988199 [Package] Contains: 03700512978190 Package: Box 2 [5 Units] In Commercial Distribution |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-04 |
| Device Publish Date | 2020-08-27 |