| Primary Device ID | 00816728020165 |
| NIH Device Record Key | 9a6885ee-67fe-4c23-ae0d-ff7dcbff7794 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Synthes Fiber Optic Cable |
| Version Model Number | Single |
| Catalog Number | 115001, 03.809.733 |
| Company DUNS | 175697908 |
| Company Name | INVUITY, INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8667117768 |
| customerservice@invuity.com | |
| Phone | 8667117768 |
| customerservice@invuity.com | |
| Phone | 8667117768 |
| customerservice@invuity.com |
| Length | 8 Feet |
| Length | 8 Feet |
| Length | 8 Feet |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816728020165 [Primary] |
| FST | Light, Surgical, Fiberoptic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816728020165]
Moist Heat or Steam Sterilization
[00816728020165]
Moist Heat or Steam Sterilization
[00816728020165]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-24 |
| Device Publish Date | 2016-09-22 |
| 00816728020172 | Intended to provide surgical site illumination from a high intensity light source. |
| 00816728020165 | Intended to provide surgical site illumination from a high intensity light source. |