| Primary Device ID | 00821925003446 |
| NIH Device Record Key | 6d144c00-d937-4e5c-92d5-77570412742a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GYRUS ACMI, INC |
| Version Model Number | 14BX |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821925003446 [Primary] |
| GS1 | 00821925009356 [Package] Package: [5 Units] In Commercial Distribution |
| EYA | Stylet, Ureteral |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-01 |
| Device Publish Date | 2024-07-24 |
| 00821925016118 | SHAH DISC LARGE 9.5 MM DIAMETER SILICONE |
| 00821925016101 | SHAH DISC SMALL 8.5 MM DIAMETER SILICONE |
| 00821925007819 | REX 6.9Fr URETEROSCOPE, 43cm |
| 00821925003446 | AMPLATZ Guidewire 0.038" (0.97mm) x 150cm Sper Stiff Body, 9cm Straight Tip |
| 00821925002579 | SEMI-RIGID GYNECOLOGIC SCISSORS, 32 CM |