| Primary Device ID | 10842289100609 |
| NIH Device Record Key | d21ae56e-8de7-42d3-8f5d-8bad8a4630d6 |
| Commercial Distribution Discontinuation | 2020-06-29 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Medisystems Button Hole Needle Set |
| Version Model Number | BH-7014 |
| Company DUNS | 061310132 |
| Company Name | MEDISYSTEMS CORPORATION |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-866-697-8243 |
| info@nxstage.com |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842289100602 [Primary] |
| GS1 | 10842289100609 [Package] Contains: 00842289100602 Package: [250 Units] Discontinued: 2020-06-29 Not in Commercial Distribution |
| FIE | Needle, Fistula |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-06-30 |
| Device Publish Date | 2016-09-16 |
| 10842289100715 | BH-7616 |
| 10842289100708 | BH-7615 |
| 10842289100685 | BH-7606 |
| 10842289100661 | BH-7605 |
| 10842289100654 | BH-7037 |
| 10842289100647 | BH-7036 |
| 10842289100630 | BH-7035 |
| 10842289100623 | BH-7016 |
| 10842289100616 | BH-7015 |
| 10842289100609 | BH-7014 |
| 10842289100593 | BH-7005 |
| 10842289100586 | BH-7007 |
| 10842289100555 | BH-7004 |
| 10842289100548 | BH-7006 |