| Primary Device ID | B504OMSM40110 |
| NIH Device Record Key | 3bed5ca9-abb1-4a6f-93e9-995c9d5007a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omega Surgical |
| Version Model Number | SM-4011 |
| 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 |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B504OMSM40110 [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 | 2024-02-23 |
| Device Publish Date | 2024-02-15 |
| B504OMSM40110 | SM-4011 |
| B504OMZMS40110 | ZMS-4011 |
| B504OMMR10MH300 | MR10MH30 |
| B504OMZM2630 | ZM-263 |