| Primary Device ID | 20886333007329 |
| NIH Device Record Key | 9bd32931-c18a-4167-8572-9ecb7cc6da24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACN™ Biopsy Needle |
| Version Model Number | ACN1610MF |
| Catalog Number | ACN1610MF |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333007325 [Primary] |
| GS1 | 20886333007329 [Package] Contains: 00886333007325 Package: Box [10 Units] In Commercial Distribution |
| KNW | Instrument, Biopsy |
| 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 | 2016-09-01 |
| 20886333007398 | ACN™ Biopsy Needle 16ga x 16cm |
| 20886333007381 | ACN™ Biopsy Needle 14ga x 10cm |
| 20886333007374 | ACN™ Biopsy Needle 18ga x 25cm |
| 20886333007367 | ACN™ Biopsy Needle 18ga x 20cm |
| 20886333007350 | ACN™ Biopsy Needle 18ga x 10cm |
| 20886333007343 | ACN™ Biopsy Needle 16ga x 20cm |
| 20886333007336 | ACN™ Biopsy Needle 20ga x 10cm |
| 20886333007329 | ACN™ Biopsy Needle 16ga x 10cm |
| 20886333007312 | ACN™ Biopsy Needle 20ga x 16cm |
| 20886333007305 | ACN™ Biopsy Needle 14ga x 20cm |
| 20886333007299 | ACN™ Biopsy Needle 18ga x 16cm |
| 20886333007282 | ACN™ Biopsy Needle 14ga x 12cm |
| 20886333007275 | ACN™ Biopsy Needle 14ga x 16cm |
| 20886333007268 | ACN™ Biopsy Needle 16ga x 25cm |
| 20886333007251 | ACN™ Biopsy Needle 20ga x 20cm |
| 20886333007237 | ACN™ Biopsy Needle 18ga x 30cm |