| Primary Device ID | 00821925037861 |
| NIH Device Record Key | 106ee69e-e145-4b7f-95cd-0970694af7f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BERKELEY SAFE-TOUCH |
| Version Model Number | 003853-902 |
| Company DUNS | 007198742 |
| Company Name | Gyrus ACMI, LLC |
| 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 | true |
| 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 | 00821925000032 [Package] Package: [10 Units] In Commercial Distribution |
| GS1 | 00821925037861 [Primary] |
| HHK | Curette, Suction, Endometrial (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2025-01-16 |
| Device Publish Date | 2016-10-07 |
| 00810008184943 - Olympus | 2025-09-29 ES-IP HD PTZ CAMERA KIT |
| 00810008185018 - Olympus | 2025-09-29 ES-IP 4K-SDI CXN |
| 00810008185032 - Olympus | 2025-09-29 ES-IP NEC M651 65" DISPLAY WALL |
| 00810008185063 - Olympus | 2025-09-29 ES-IP DVI/HDMI OUTPUT |
| 00821925047150 - Olympus | 2025-09-29 ES-IP DUAL IN-ROOM System - EXPANDED 48U |
| 00821925047242 - Olympus | 2025-09-29 ES-IP iOR BWK Hamburg ER (with rack) |
| 00821925047259 - Olympus | 2025-09-29 ES-IP iOR BWK Hamburg ER (no rack) |
| 00821925047266 - Olympus | 2025-09-29 ES-IP iOR BWK Hamburg OP (with rack) |