| Primary Device ID | 10816203022575 |
| NIH Device Record Key | 19f29bf3-ffb5-4006-a389-d1c00015de5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O-Wrap |
| Version Model Number | OW0419 |
| Company DUNS | 625272232 |
| Company Name | ORIGEN BIOMEDICAL, INC. |
| Device Count | 10 |
| 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 | |
| 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 | |
| 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 | |
| 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 | 00816203022578 [Unit of Use] |
| GS1 | 10816203022575 [Primary] |
| KJG | Tube, Tissue Culture |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-04 |
| Device Publish Date | 2023-03-27 |
| 10816203022575 | O-Wrap, overwrap pouch for freezing, 4X19cm |
| 00816203022615 | O-Wrap, overwrap pouch for freezing,19x36cm |
| 00816203022608 | O-Wrap, overwrap pouch for freezing, 14x30cm |
| 00816203022592 | O-Wrap, overwrap pouch for freezing, 9x18cm |
| 00816203022585 | O-Wrap, overwrap pouch for freezing, 9x9cm. |
| 00816203022257 | O-Wrap, overwrap pouch for freezing, 24x36cm |
| 00816203022226 | O-Wrap, overwrap pouch for freezing,19x50cm |
| 00816203022202 | O-Wrap overwrap 3-layer pouch for freezing, 14x30cm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() O-WRAP 98492745 not registered Live/Pending |
OriGen Biomedical, Inc. 2024-04-10 |
![]() O-WRAP 78740496 3148588 Dead/Cancelled |
Visco, Anthony G. 2005-10-26 |