Primary Device ID | 07640138980282 |
NIH Device Record Key | 584873ba-500d-410e-b77f-29332aa6a345 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RegenKit®-BCT-4 |
Version Model Number | RK-BCT-4 |
Company DUNS | 482206518 |
Company Name | REGEN LAB SA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07640138980282 [Primary] |
ORG | Platelet And Plasma Separator For Bone Graft Handling |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-04-09 |
Device Publish Date | 2016-09-15 |
07640138981012 - RegenET | 2022-07-06 Kit containing 20 x R-ET-3 in a carton box |
07640138981630 - RegenKit-BCT-3 (20ml)/RegenPlasma | 2022-04-11 RegenKit-BCT-3 (20ml) containing 3 RegenBCT tubes 20 ml. |
07640138981593 - RegenKit-THT-3/RegenCell® | 2021-11-03 RegenKit-THT-3 containing 3 x R-THT20 tubes. |
07640138980329 - Accessory Set | 2020-10-21 |
07640138981364 - RegenET | 2020-03-03 |
07640138980244 - RegenKit®-THT-1/RegenCell® | 2019-06-25 |
07640138980251 - RegenKit®-THT-4/RegenCell® | 2019-06-25 |
07640138980565 - RegenKit®-THT-2/RegenCell® | 2019-06-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() REGENKIT 79062709 3718804 Live/Registered |
RegenLab USA LLC 2008-09-19 |