| Primary Device ID | M20681501 |
| NIH Device Record Key | 6c5df596-e111-4ab0-87e8-94910e0c202e |
| Commercial Distribution Discontinuation | 2021-02-28 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Teirstein Edge™ device organizer |
| Version Model Number | 8150 |
| Company DUNS | 008999906 |
| Company Name | Vascular 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 | false |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | M20681500 [Primary] |
| HIBCC | M20681501 [Package] Contains: M20681500 Package: Box [10 Units] Discontinued: 2021-02-28 Not in Commercial Distribution |
| FTY | Tape, Measuring, Rulers And Calipers |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-06-09 |
| Device Publish Date | 2016-09-05 |
| M20677101 - Vascular Solutions Custom Access Kit | 2023-06-09 |
| M20677141 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677181 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677191 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677201 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677211 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677221 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677231 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |