| Primary Device ID | 00853460007221 |
| NIH Device Record Key | 95a1cd5c-20b8-4058-b99e-db413237277d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Imaging (ZEOS) |
| Version Model Number | 84-10-2120 |
| Catalog Number | 84-10-2120 |
| Company DUNS | 065016344 |
| Company Name | SANTA BARBARA IMAGING SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Serial Number | true |
| 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 |
| Phone | 805-770-2110 |
| Info@sbimagingsystems.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853460007221 [Primary] |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00853460007221]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-27 |
| Device Publish Date | 2018-07-27 |
| 00853460007443 | ZEOS 4K UHD CAMERA HEAD C-MOUNT 3CMOS |
| 00853460007436 | ZEOS 4K UHD CAMERA HEAD 1CMOS |
| 00853460007429 | ZEOS 4K UHD CAMERA HEAD C-MOUNT 1CMOS |
| 00853460007412 | CAMERA HEAD HD C-MOUNT 3CMOS |
| 00853460007405 | CAMERA HEAD HD C-MOUNT 1CMOS |
| 00853460007320 | ZEOS 4K UHD CAMERA HEAD 3CMOS |
| 00853460007290 | ZEOS 4K UHD CAMERA CONTROL UNIT |
| 00853460007221 | CAMERA HEAD HD 1CMOS |
| 00853460007191 | STORZ ADAPTER |
| 00853460007184 | ACMI ADAPTER |
| 00853460007177 | WOLF ADAPTER |
| 00853460007160 | LIGHTCABLE 3M BLUE W/ STORZ ADAPTER |
| 00853460007153 | LIGHTCABLE 3M GREY W/ STORZ ADAPTER |
| 00853460007108 | TABLET USER INTERFACE |
| 00853460007092 | CAMERA HEAD HD 3CMOS |
| 00853460007085 | CAMERA CONTROL UNIT HD 3-IN-1 PLUS |