| Primary Device ID | B504OMS8605150 |
| NIH Device Record Key | e6682188-bef7-4ab0-ad22-9d0e887d2e17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | De Soutter |
| Version Model Number | S86-0515 |
| Company DUNS | 016889401 |
| Company Name | Provision |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | true |
| 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 |
|---|---|
| HIBCC | B504OMS8605150 [Primary] |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-23 |
| Device Publish Date | 2020-09-15 |
| B504OMS8976750 | S89-7675 |
| B504OMS8966360 | S89-6636 |
| B504OMS8605150 | S86-0515 |
| B504OMS843600 | S84-360 |
| 00810041638632 | S89-7675 |
| 00810041638625 | S89-6636 |
| 00810041638618 | S86-0515 |
| 00810041638601 | S84-360 |
| B504OMS8915730 | S89-1573 |
| 00810041639776 | S89-1573 |