| Primary Device ID | 00842289100138 |
| NIH Device Record Key | 77a5251b-0e5a-407d-a34e-926924be867c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medisystems Button Hole Needle Set with SteriPick |
| Version Model Number | BH-7035PE |
| 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 | 15 Gauge |
| Needle Gauge | 15 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 | 00842289100138 [Primary] |
| FIE | Needle, Fistula |
| 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 | 2016-09-16 |
| 10842289100692 | BH-7606PE |
| 10842289100678 | BH-7605PE |
| 10842289100579 | BH-7004PE |
| 10842289100562 | BH-7006PE |
| 10842289100531 | BH-4006PE |
| 10842289100524 | BH-7005PE |
| 10842289100517 | BH-4005PE |
| 00842289100183 | MEDISYSTEMS SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 17G X 3/5" W/ STERIPICK INCLUDED WITH TWIN |
| 00842289100152 | MEDISYSTEMS SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICK INCLUDED WITH TWIN |
| 00842289100138 | MEDISYSTEMS SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 15G X 3/5" W/ STERIPICK INCLUDED WITH TWIN |
| 00842289100107 | MEDISYSTEMS SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" WITH STERIPICK INCLUDED WITH TWIN |
| 00842289100077 | MEDISYSTEMS SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 16G X 1" WITH STERIPICK INCLUDED WITH TWIN |
| 00842289100053 | MEDISYSTEMS SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 14G X 1" W/ STERIPICK INCLUDED WITH TWINPA |
| 00842289100022 | MEDISYSTEMS SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 15G X 1" WITH STERIPICK INCLUDED WITH TWIN |