| Primary Device ID | 10816203020113 |
| NIH Device Record Key | a5424e93-a6d8-47c5-a8bc-7c7aeee7a27c |
| Commercial Distribution Discontinuation | 2024-12-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Injection Spike |
| Version Model Number | IBS-X |
| Company DUNS | 625272232 |
| Company Name | ORIGEN BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10816203020113 [Primary] |
| GS1 | 20816203020110 [Package] Package: Case [50 Units] Discontinued: 2024-12-11 Not in Commercial Distribution |
| KJG | Tube, Tissue Culture |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-12-12 |
| Device Publish Date | 2016-09-23 |
| 10816203021646 | DMSO-Resistant Bag Spike with needle injection port , bulk packed |
| 10816203020113 | DMSO-Resistant Bag Spike with non- ahdered needle injection port, case of 50 |
| 10816203020106 | DMSO-Resistant Bag Spike with needle injection port, case of 50 |