| Primary Device ID | 10886333214997 |
| NIH Device Record Key | 0a37c8b4-f8e0-4bd0-bb8b-ce4807c34755 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Percutaneous Micro-Introducer Kit |
| Version Model Number | 497801 |
| Catalog Number | 497801 |
| Company DUNS | 140727624 |
| Company Name | ARGON MEDICAL DEVICES, 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 | 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 |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com | |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333214990 [Primary] |
| GS1 | 10886333214997 [Package] Contains: 00886333214990 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 20886333214994 [Package] Contains: 00886333214990 Package: Box [50 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-09 |
| 10886333215079 | Percutaneous Micro-Introducer Kit 4F |
| 10886333215062 | 5F Percutaneous Micro-Introducer Kit |
| 10886333215055 | 4F Percutaneous Micro-Introducer Kit |
| 10886333215048 | 5F Percutaneous Micro-Introducer Kit |
| 10886333215031 | 4F Percutaneous Micro-Introducer Kit |
| 10886333215024 | 5F Percutaneous Micro-Introducer Kit |
| 10886333215017 | 4F Percutaneous Micro-Introducer Kit |
| 10886333215000 | 5F Percutaneous Micro-Introducer Kit |
| 10886333214997 | 4F Percutaneous Micro-Introducer Kit |