Invuity® Fiber Optic Cable FC1B
GUDID 00816728020226
The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to provide surgical site illumination from a high intensity light source.
INVUITY, INC.
Fibreoptic light cable| Primary Device ID | 00816728020226 |
| NIH Device Record Key | b466cdf7-2f0a-4af6-98b7-0db89c32c01c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invuity® Fiber Optic Cable |
| Version Model Number | Bifurcated, 11.5ft |
| Catalog Number | FC1B |
| 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 |
Customer Support Contacts
Device Dimensions
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
| Length | 11.5 Feet |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816728020226 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090070
FDA Product Code
| FST | Light, Surgical, Fiberoptic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
[00816728020226]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-24 |
| Device Publish Date | 2016-09-22 |
On-Brand Devices [Invuity® Fiber Optic Cable]
| 00816728020226 | The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to pr |
| 00816728020219 | The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to pr |
| 00816728020202 | The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to pr |
| 00816728020196 | The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to pr |
| 00816728020189 | The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to pr |
Trademark Results [Invuity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INVUITY 77976634 3604233 Live/Registered |
INVUITY, INC. 2007-09-28 |
 INVUITY 77292075 not registered Dead/Abandoned |
INVUITY, INC. 2007-09-28 |
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