| Primary Device ID | 00821925003736 |
| NIH Device Record Key | c6693836-62ef-4e16-91a0-0aa8f5714d2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | USA Elite System™ Standard Flow Resectoscope Visual Obturator 28 Fr, |
| Version Model Number | EVOR-28 |
| Company DUNS | 007198742 |
| Company Name | Gyrus Acmi, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 00821925003736 [Primary] |
| FAS | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
| HIH | Hysteroscope (And Accessories) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
[00821925003736]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-14 |
| 00821925043916 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 150 Micron |
| 00821925043930 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron |
| 00821925043978 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron |
| 00821925043992 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 365 Micron |
| 00821925044074 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 940 Micron |
| 00821925002074 - USA Elite System | 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow |
| 00821925002098 - USA Elite System | 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow |
| 00821925002111 - USA Elite System | 2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold |