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 Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable 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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