| Primary Device ID | 10886333215093 |
| NIH Device Record Key | 53df547b-68bb-4627-aa3e-05917c3bd5b0 |
| Commercial Distribution Discontinuation | 2017-08-07 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | One Step Micro-Introducer System |
| Version Model Number | 497820 |
| Catalog Number | 497820 |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333215096 [Primary] |
| GS1 | 10886333215093 [Package] Contains: 00886333215096 Package: Box [10 Units] Discontinued: 2017-08-07 Not in Commercial Distribution |
| GS1 | 20886333215090 [Package] Contains: 00886333215096 Package: Box [50 Units] Discontinued: 2017-08-07 Not 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 | 4 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2016-09-09 |
| 10886333215376 | One Step Micro-Introducer System 4F |
| 10886333215369 | One Step Micro-Introducer System 7F |
| 10886333215352 | One Step Micro-Introducer System 6F |
| 10886333215345 | One Step Micro-Introducer System 5F |
| 10886333215321 | One Step Micro-Introducer System 7F |
| 10886333215314 | One Step Micro-Introducer System 8F |
| 10886333215307 | One Step Micro-Introducer System 7F |
| 10886333215291 | One Step Micro-Introducer System 7F |
| 10886333215284 | One Step Micro-Introducer System 5F |
| 10886333215277 | One Step Micro-Introducer System 4F |
| 10886333215260 | One Step Micro-Introducer System 4F |
| 10886333215253 | One Step Micro-Introducer System 6F |
| 10886333215246 | One Step Micro-Introducer System 6F |
| 10886333215239 | One Step Micro-Introducer System 6F |
| 10886333215222 | One Step Micro-Introducer System 6F |
| 10886333215215 | One Step Micro-Introducer System 8F |
| 10886333215192 | One Step Micro-Introducer System 6F |
| 10886333215178 | One Step Micro-Introducer System 7F |
| 10886333215154 | One Step Micro-Introducer System 6F |
| 10886333215147 | One Step Micro-Introducer System 6F |
| 10886333215130 | One Step Micro-Introducer System 6F |
| 10886333215123 | One Step Micro-Introducer System 5F |
| 10886333215116 | One Step Micro-Introducer System 5F |
| 10886333215093 | One Step Micro-Introducer System 4F |