| Primary Device ID | 10816349013628 |
| NIH Device Record Key | c51bdc25-c327-44ea-9cd9-4527a8739313 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GuideRight |
| Version Model Number | 404844-1 |
| Catalog Number | 404844-1 |
| Company DUNS | 031108704 |
| Company Name | Lake Region Medical |
| 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 |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816349013621 [Primary] |
| GS1 | 10816349013628 [Package] Contains: 00816349013621 Package: [5 Units] In Commercial Distribution |
| DQX | Wire, Guide, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-04-01 |
| Device Publish Date | 2026-03-24 |
| 10816349013666 | 404560-1 |
| 10816349013659 | 404555-1 |
| 10816349013642 | 404568-1 |
| 10816349013635 | 404878-1 |
| 10816349013628 | 404844-1 |
| 10816349013611 | 404843-1 |
| 10816349013604 | 404840-1 |
| 10816349013598 | 404617-1 |
| 10816349013581 | 404610-1 |
| 10816349013574 | 404577-1 |
| 10816349013567 | 404571-1 |
| 10816349013550 | 404578-1 |
| 10816349013543 | 404570-1 |
| 10816349013536 | 404569-1 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GUIDERIGHT 87852320 not registered Live/Pending |
GuideRight Assessments, LLC 2018-03-27 |
![]() GUIDERIGHT 77413917 3772274 Dead/Cancelled |
Dreambox Learning Inc. 2008-03-05 |
![]() GUIDERIGHT 75916824 not registered Dead/Abandoned |
Virtual Carrier Network, Inc. 2000-02-10 |
![]() GUIDERIGHT 75222634 2181424 Dead/Cancelled |
Daig Corporation 1997-01-08 |