| Primary Device ID | 20886333224214 |
| NIH Device Record Key | f7522390-8cd5-4a47-93e6-d8e28f7e85ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | One-Piece/Tuohy-Borst Introducer Tray |
| Version Model Number | 497456LF |
| Catalog Number | 497456LF |
| Company DUNS | 140727624 |
| Company Name | ARGON MEDICAL DEVICES, 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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333224210 [Primary] |
| GS1 | 20886333224214 [Package] Contains: 00886333224210 Package: Box [10 Units] In Commercial Distribution |
| DRE | Dilator, Vessel, For Percutaneous Catheterization |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2018-04-24 |
| 20886333224214 | One-Piece/Tuohy-Borst Introducer Tray without Lidocaine |
| 20886333214963 | One-Piece/Tuohy-Borst Introducer Tray 8.5F |
| 20886333214642 | One-Piece/Tuohy-Borst Introducer Tray 9F |
| 20886333214635 | One-Piece/Tuohy-Borst Introducer Tray 8.5F |
| 20886333214628 | One-Piece/Tuohy-Borst Introducer Tray 8F |
| 20886333214611 | One-Piece/Tuohy-Borst Introducer Tray 7F |
| 20886333214604 | One-Piece/Tuohy-Borst Introducer Tray 6F |