| Primary Device ID | 20886333226317 |
| NIH Device Record Key | 6db8377f-244f-4dd4-a50a-cf2fff716d5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Co-Axial Introducer Needle |
| Version Model Number | MCXS1616BX |
| Catalog Number | MCXS1616BX |
| 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 |
| 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 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333226313 [Primary] |
| GS1 | 20886333226317 [Package] Contains: 00886333226313 Package: Box [10 Units] In Commercial Distribution |
| KNW | Instrument, Biopsy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-29 |
| Device Publish Date | 2022-07-21 |
| 20886333002560 | Co-Axial Introducer Needle 17ga x 3.9cm |
| 20886333002553 | Co-Axial Introducer Needle 15ga x 5.1cm |
| 20886333002546 | Co-Axial Introducer Needle 15ga x 11.8cm |
| 20886333002539 | Co-Axial Introducer Needle 15ga x 9.9cm |
| 20886333002522 | Co-Axial Introducer Needle 15ga x 10.6cm |
| 20886333002515 | Co-Axial Introducer Needle 15ga x 10.3cm |
| 20886333002508 | Co-Axial Introducer Needle 15ga x 11.5cm |
| 20886333002492 | Co-Axial Introducer Needle 15ga x 11.1cm |
| 20886333002485 | Co-Axial Introducer Needle 15ga x 16.8cm |
| 20886333002478 | Co-Axial Introducer Needle 17ga x 3.5cm |
| 20886333002461 | Co-Axial Introducer Needle 15ga x 3.9cm |
| 20886333002454 | Co-Axial Introducer Needle 17ga x 4.6cm |
| 20886333002447 | Co-Axial Introducer Needle 17ga x 6.8cm |
| 20886333002430 | Co-Axial Introducer Needle 17ga x 4.3cm |
| 20886333002423 | Co-Axial Introducer Needle 17ga x 5.1cm |
| 20886333002416 | Co-Axial Introducer Needle 17ga x 7.5cm |
| 20886333002409 | Co-Axial Introducer Needle 17ga x 11.8cm |
| 20886333002393 | Co-Axial Introducer Needle 15ga x 14.9cm |
| 20886333002386 | Co-Axial Introducer Needle 13ga x 10.3cm |
| 20886333002379 | Co-Axial Introducer Needle 13ga x 3.5cm |
| 20886333002362 | Co-Axial Introducer Needle 13ga x 3.9cm |
| 20886333002355 | Co-Axial Introducer Needle 13ga x 4.6cm |
| 20886333002348 | Co-Axial Introducer Needle 13ga x 6.8cm |
| 20886333002331 | Co-Axial Introducer Needle 13ga x 4.3cm |
| 20886333002324 | Co-Axial Introducer Needle 13ga x 5.1cm |
| 20886333002317 | Co-Axial Introducer Needle 13ga x 7.5cm |
| 20886333002300 | Co-Axial Introducer Needle 13ga x 11.8cm |
| 20886333002294 | Co-Axial Introducer Needle 15ga x 6.8cm |
| 20886333002287 | Co-Axial Introducer Needle 13ga x 10.6cm |
| 20886333002270 | Co-Axial Introducer Needle 17ga x 9.9cm |
| 20886333002256 | Co-Axial Introducer Needle 13ga x 11.1cm |
| 20886333002232 | Co-Axial Introducer Needle 13ga x 14.9cm |
| 20886333002225 | Co-Axial Introducer Needle 15ga x 3.5cm |
| 20886333002218 | Co-Axial Introducer Needle 15ga x 7.5cm |
| 20886333002201 | Co-Axial Introducer Needle 15ga x 4.6cm |
| 20886333002195 | Co-Axial Introducer Needle 13ga x 9.9cm |
| 20886333002188 | Co-Axial Introducer Needle 19ga x 12.1cm |
| 20886333002171 | Co-Axial Introducer Needle 15ga x 4.3cm |
| 20886333002164 | Co-Axial Introducer Needle 17ga x 10.6cm |
| 20886333002157 | Co-Axial Introducer Needle 19ga x 15.2cm |
| 20886333002133 | Co-Axial Introducer Needle 19ga x 11.4cm |
| 20886333002126 | Co-Axial Introducer Needle 19ga x 11.8cm |
| 20886333002119 | Co-Axial Introducer Needle 19ga x 10.6cm |
| 20886333002102 | Co-Axial Introducer Needle 19ga x 10.9cm |
| 20886333002096 | Co-Axial Introducer Needle 19ga x 10.2cm |
| 20886333002089 | Co-Axial Introducer Needle 19ga x 7.8cm |
| 20886333002072 | Co-Axial Introducer Needle 19ga x 5.4cm |
| 20886333002065 | Co-Axial Introducer Needle 19ga x 4.6cm |
| 20886333002041 | Co-Axial Introducer Needle 17ga x 14.6cm |
| 20886333002034 | Co-Axial Introducer Needle 17ga x 10.3cm |