| Primary Device ID | 00853460007061 |
| NIH Device Record Key | 8420bb36-2f95-4769-8f15-daf594ff0a82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trinity |
| Version Model Number | 81-10-2100 |
| Catalog Number | 81-10-2100 |
| 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 | 00853460007061 [Primary] |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00853460007061]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-06-22 |
| Device Publish Date | 2017-12-07 |
| 00853460007344 | Tablet User Interface |
| 00853460007337 | TRINITY HD Camera Control Unit |
| 00853460007313 | TRINITY 4K Camera Head 3 CMOS - C-MOUNT |
| 00853460007306 | TRINITY HD Camera Head 3 CMOS - C-MOUNT |
| 00853460007146 | TRINITY 4K Camera Head 3 CMOS - Eyecup |
| 00853460007139 | TRINITY 4K Camera Control Unit |
| 00853460007078 | Tablet User Interface |
| 00853460007061 | TRINITY HD Camera Head 3 CMOS - Eyecup |
| 00853460007054 | TRINITY HD Camera Control Unit |