| Primary Device ID | 00850071684216 |
| NIH Device Record Key | 9d0a4437-cf4c-48ab-b362-c8683ee375bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Realstar Surgical |
| Version Model Number | RSSI-130-179 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850071684216 [Primary] |
| HDC | Tenaculum, Uterine |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
[00850071684216]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-29 |
| Device Publish Date | 2025-01-21 |
| 00860012999699 | Vu-Max (Pederson), Large |
| 00860012999682 | Vu-Max (Pederson) , Medium |
| 00860012999675 | Pederson Vaginal Speculum, Large |
| 00860012999651 | Pederson Vaginal Speculum, Small |
| 00860012999644 | Graves Vaginal Speculum, X-Large |
| 00860012999637 | Graves Vaginal Speculum, Small |
| 00860012999620 | Graves Vaginal Speculum, Medium |
| 00860012999613 | Graves Vaginal Speculum , Large |
| 00850071684155 | 4-Way Expander (X-Large) Coated |
| 00850071684148 | 4-Way Expander (X-Large) |
| 00850071684131 | 4-Way Expander (Large) Coated |
| 00850071684124 | 4-Way Expander (Large) |
| 00850071684117 | 4-Way Expander (Medium) Coated |
| 00850071684100 | 4-Way Expander (Medium) |
| 00850071684094 | Vu-Max (Graves), Large |
| 00850071684087 | Vu-Max (Graves), Medium |
| 00850071684070 | Vu-More (Graves), Large |
| 00850071684063 | Vu-More (Graves), Medium |
| 00850071684056 | Weisman Speculum 90° (Right Open), Large |
| 00850071684049 | Weisman Speculum 90° (Right Open), Medium |
| 00850071684032 | Weisman Speculum 90° (Left Open), Large |
| 00850071684025 | Weisman Speculum 90° (Left Open), Medium |
| 00850071684018 | Collin Speculum, Large |
| 00850071684001 | Collin Speculum, Medium |
| 00860012999606 | Emmett Hook |
| 00850071684292 | Dressing Forceps, 25 cm |
| 00850071684285 | Dressing Forceps, 20 cm |
| 00850071684278 | Tissue Forceps, 25 cm |
| 00850071684261 | Tissue Forceps, 20 cm |
| 00850071684254 | Rigby Retractor |
| 00850071684247 | Kogan Endocervical Speculum, 3mm |
| 00850071684230 | Kogan Endocervical Speculum, 5mm |
| 00850071684223 | Ring Forceps |
| 00850071684216 | Three-Prong Hook |
| 00850071684209 | Two-Prong Hook |
| 00850071684193 | Straight Hook |
| 00850071684186 | Atraumatic Tenaculum |
| 00850071684179 | Iris Hook |
| 00850071684162 | Schroeder Tenaculum(Insulated Tips) |