| Primary Device ID | 10816349015097 |
| NIH Device Record Key | ff862f2d-d55c-45c8-b4b0-17b9e8b45930 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intuition |
| Version Model Number | IN32180J |
| Catalog Number | ABFBF-007V |
| 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 |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Guidewire Length | 180 Centimeter |
| Guidewire Diameter | 0.032 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816349015090 [Primary] |
| GS1 | 10816349015097 [Package] Contains: 00816349015090 Package: Carton [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 | 2026-01-14 |
| Device Publish Date | 2026-01-06 |
| 10816349015097 - Intuition | 2026-01-14 |
| 10816349015097 - Intuition | 2026-01-14 |
| 10816349014861 - PV-Tracker™ | 2025-02-20 |
| 08714729761761 - ZIPwire™ | 2024-06-28 |
| 08714729761778 - ZIPwire™ | 2024-06-28 |
| 08714729761785 - ZIPwire™ | 2024-06-28 |
| 08714729761792 - ZIPwire™ | 2024-06-28 |
| 08714729761808 - ZIPwire™ | 2024-06-28 |
| 08714729755333 - ZIPwire™ | 2024-06-28 |