| Primary Device ID | 38800018900438 |
| NIH Device Record Key | b7a5f72b-7fd3-4d04-8b36-7f0067095193 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DBC Sooji Hand Needle |
| Version Model Number | SooJi.Hand |
| Catalog Number | SooJi.Hand |
| Company DUNS | 689846367 |
| Company Name | Dong Bang Medical co.,Ltd. |
| Device Count | 100 |
| 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 | 800-722-8775 |
| customerservice@lhasaoms.com | |
| Phone | 800-722-8775 |
| customerservice@lhasaoms.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800018900437 [Unit of Use] |
| GS1 | 18800018900434 [Primary] |
| GS1 | 28800018900431 [Package] Contains: 18800018900434 Package: Case [10 Units] In Commercial Distribution |
| GS1 | 38800018900438 [Package] Contains: 28800018900431 Package: Master Case [10 Units] In Commercial Distribution |
| MQX | Needle, Acupuncture, Single Use |
| 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 | 2016-08-09 |