| Primary Device ID | 20886333004908 |
| NIH Device Record Key | a2d31ddf-87e9-4754-a470-58e5df2d2fa6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Screw Dilator |
| Version Model Number | 630738025 |
| Catalog Number | 630738025 |
| 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 | 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 |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com | |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com | |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com | |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com | |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com | |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com | |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com | |
| 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 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 | 00886333004904 [Primary] |
| GS1 | 20886333004908 [Package] Contains: 00886333004904 Package: Box [10 Units] In Commercial Distribution |
| GCC | Dilator, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-12 |
| 20886333004960 | Screw Dilator 16F x 25cm |
| 20886333004953 | Screw Dilator 14F x 25cm |
| 20886333004946 | Screw Dilator 12F x 25cm |
| 20886333004939 | Screw Dilator 10F x 25cm |
| 20886333004922 | Screw Dilator 9F x 25cm |
| 20886333004915 | Screw Dilator 8F x 25cm |
| 20886333004908 | Screw Dilator 7Fr x 25cm |