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 |