| 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 |
| 00821925045989 - Olympus | 2025-04-17 nCare 4K Cable, DisplayPort to HDMI, 6ft or (1.83 m), C2G, 54326 |
| 00821925045996 - Olympus | 2025-04-17 nCare 4K Cable Assembly, 1694F, 3G-SDI, 4K BNC Male to Male, 6 ft. or (1.83 m), Black |
| 00821925046610 - Olympus | 2025-04-17 nCare 4K Keyboard, All-in-one, Compact, Medical, Washable, USB, White |
| 00821925047075 - Olympus | 2025-04-17 nCare 4K Footswitch |
| 00821925047082 - Olympus | 2025-04-17 nCare 4K Audio Cables |
| 00821925045941 - Olympus | 2025-04-16 nCare 4K 21.5" Medical Touch Panel |
| 00821925045958 - Olympus | 2025-04-16 nCare 4K Cable Assembly, DVI-D to DVI-D, Single Link TMDS, Black, 6.0 ft. or (1.83 m) |
| 00821925045965 - Olympus | 2025-04-16 nCare 4K Cable Assembly, HDMI M to DVI-D M, Single Link, Black, 6 ft. or (1.83 m) |