Primary Device ID | 00816203022257 |
NIH Device Record Key | c128e586-7ed4-4455-b825-6ffd949c782a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | O-Wrap |
Version Model Number | OW2436 |
Company DUNS | 625272232 |
Company Name | ORIGEN BIOMEDICAL, INC. |
Device Count | 5 |
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@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com | |
Phone | 512-474-7278 |
regulatory@origenbio.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00816203022257 [Unit of Use] |
GS1 | 10816203022254 [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 | 2023-04-11 |
Device Publish Date | 2023-04-03 |
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 |