Primary Device ID | 00860012999651 |
NIH Device Record Key | aa7ce6a9-f100-402a-93af-fc12b09d5a83 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Realstar Surgical |
Version Model Number | RSSI-130-203 |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860012999651 [Primary] |
HDF | Speculum, Vaginal, Metal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00860012999651]
Moist Heat or Steam Sterilization
[00860012999651]
Moist Heat or Steam Sterilization
[00860012999651]
Moist Heat or Steam Sterilization
[00860012999651]
Moist Heat or Steam Sterilization
[00860012999651]
Moist Heat or Steam Sterilization
[00860012999651]
Moist Heat or Steam Sterilization
[00860012999651]
Moist Heat or Steam Sterilization
[00860012999651]
Moist Heat or Steam Sterilization
[00860012999651]
Moist Heat or Steam Sterilization
[00860012999651]
Moist Heat or Steam Sterilization
[00860012999651]
Moist Heat or Steam Sterilization
[00860012999651]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-01-20 |
Device Publish Date | 2025-01-12 |
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) |