SideWise
GUDID 00861062000304
600 micrometer, angled tip, laser fiber
FIBER OPTIC FABRICATIONS, INC.
General/multiple surgical laser system beam guide, single-use, sterile| Primary Device ID | 00861062000304 |
| NIH Device Record Key | f0e1b2aa-655e-4cbe-a6d0-0a8c4699c784 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SideWise |
| Version Model Number | SW-0001 |
| Company DUNS | 879359610 |
| Company Name | FIBER OPTIC FABRICATIONS, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861062000304 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120810
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
[00861062000304]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-12 |
Devices Manufactured by FIBER OPTIC FABRICATIONS, INC.
| 00861062000359 - LithoWise | 2024-11-07 400 micrometer laser fiber |
| 00861062000342 - LithoWise | 2018-08-22 940 micrometer laser fiber |
| 00861062000304 - SideWise | 2018-07-06600 micrometer, angled tip, laser fiber |
| 00861062000304 - SideWise | 2018-07-06 600 micrometer, angled tip, laser fiber |
| 00861062000311 - LithoWise | 2018-07-06 272 micrometer laser fiber |
| 00861062000328 - LithoWise | 2018-07-06 365 micrometer laser fiber |
| 00861062000335 - LithoWise | 2018-07-06 550 micrometer laser fiber |
Trademark Results [SideWise]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIDEWISE 88364589 not registered Live/Pending |
H.J. Heinz US Brands LLC 2019-03-31 |
 SIDEWISE 76649623 3436590 Dead/Cancelled |
WWSI AMERICAS, INC. 2005-10-31 |
 SIDEWISE 75250321 2138922 Dead/Cancelled |
Spinealine Company, Incorporated, The 1997-03-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.