| Primary Device ID | 00821925004023 |
| NIH Device Record Key | f7962644-be16-4553-bfbe-b1e7a3df4b3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flexible Cystoscopic Biopsy Forceps Telescoping Jaws, Stem Only 8 Fr, |
| Version Model Number | 331AS8 |
| Company DUNS | 007198742 |
| Company Name | Gyrus Acmi, Inc. |
| 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 | 00821925004023 [Primary] |
| KOA | SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
[00821925004023]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-12 |
| Device Publish Date | 2018-09-11 |
| 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 |