| Primary Device ID | B227700004 |
| NIH Device Record Key | 01de45b0-dfe4-437a-a011-e2219e9e3cb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vein Ablation Pack |
| Version Model Number | 700004 |
| Catalog Number | 700004 |
| Company DUNS | 608625823 |
| Company Name | NORTH EAST SCIENTIFIC INC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | 2037562111 |
| matt@smarthealth-care.com | |
| Phone | 2037562111 |
| matt@smarthealth-care.com | |
| Phone | 2037562111 |
| matt@smarthealth-care.com | |
| Phone | 2037562111 |
| matt@smarthealth-care.com | |
| Phone | 2037562111 |
| matt@smarthealth-care.com | |
| Phone | 2037562111 |
| matt@smarthealth-care.com | |
| Phone | 2037562111 |
| matt@smarthealth-care.com | |
| Phone | 2037562111 |
| matt@smarthealth-care.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B227700004 [Primary] |
| LRP | Tray, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-11 |
| B227700005 | Vein ablation pack. Stradis Part # 682-2187. 1 pack per case. |
| B227700004 | Vein ablation pack. Stradis Part # 682-2129. 5 Packs per case. |