| Primary Device ID | 10850012846694 |
| NIH Device Record Key | d400d75d-bbee-44e0-b512-3eeaaf236010 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GentleGuide |
| Version Model Number | 082030 |
| Catalog Number | 082030 |
| Company DUNS | 603420183 |
| Company Name | LSI Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850012846697 [Primary] |
| GS1 | 10850012846694 [Package] Contains: 00850012846697 Package: Carton [12 Units] In Commercial Distribution |
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-19 |
| Device Publish Date | 2026-03-11 |
| 10850012846694 - GentleGuide | 2026-03-19GENTLEGUIDE™ DEVICE |
| 10850012846694 - GentleGuide | 2026-03-19 GENTLEGUIDE™ DEVICE |
| 10850012846601 - COR-KNOT MESO | 2026-03-03 COR-KNOT MESO XL Device |
| 10850012846618 - COR-KNOT MESO | 2026-03-03 COR-KNOT MESO XL Device Twin Pack |
| 00850012846673 - multiSTATION® ViewSite™ Retractor | 2026-01-29 multiSTATION® ViewSite™ Retractor |
| 10850012846687 - SVELTEFELT™ QUICK PLEDGE™ | 2026-01-29 SVELTEFELT™ QUICK PLEDGE™ UNIT |
| 10850012846519 - C1® DEPTH LIMITER | 2025-12-16 C1® DEPTH LIMITER |
| 10850012846656 - COR-KNOT MICRO | 2025-12-16 COR-KNOT MICRO® XL |
| 10850012846663 - COR-KNOT MICRO | 2025-12-16 COR-KNOT MICRO® XL DEVICE TWIN PACK |