| Primary Device ID | 00850071684308 |
| NIH Device Record Key | 11aac8af-582b-47db-9aaa-3788a3811341 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REALSTAR SURGICAL INSTRUMENTS |
| Version Model Number | RSSI-878-191 |
| Company DUNS | 645842282 |
| Company Name | REAL STAR SURGICAL INSTRUMENTS |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850071684308 [Primary] |
| FXG | Specula Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-17 |
| Device Publish Date | 2025-09-09 |
| 00850071684308 - REALSTAR SURGICAL INSTRUMENTS | 2025-09-17SMOKE EVACUATOR TUBING FOR LEEP AND LASER VAGINAL SPECULA Specula Accessory |
| 00850071684308 - REALSTAR SURGICAL INSTRUMENTS | 2025-09-17 SMOKE EVACUATOR TUBING FOR LEEP AND LASER VAGINAL SPECULA Specula Accessory |
| 00850071684162 - Realstar Surgical | 2025-01-29 Schroeder Tenaculum(Insulated Tips) |
| 00850071684179 - Realstar Surgical | 2025-01-29 Iris Hook |
| 00850071684186 - Realstar Surgical | 2025-01-29 Atraumatic Tenaculum |
| 00850071684193 - Realstar Surgical | 2025-01-29 Straight Hook |
| 00850071684209 - Realstar Surgical | 2025-01-29 Two-Prong Hook |
| 00850071684216 - Realstar Surgical | 2025-01-29 Three-Prong Hook |
| 00850071684223 - Realstar Surgical | 2025-01-29 Ring Forceps |