Primary Device ID | 08500331310066 |
NIH Device Record Key | 5848d1c3-58d9-486d-ad84-902143f53760 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RegenKit®-BCT-3 |
Version Model Number | RK-BCT-3 |
Company DUNS | 087434117 |
Company Name | Regenlab USA LLC |
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 | 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 |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08500331310066 [Primary] |
ORG | Platelet And Plasma Separator For Bone Graft Handling |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-06 |
Device Publish Date | 2021-08-27 |
00850033131109 - RegenLab USA | 2024-04-26 RegenKit-THT-BMC, Ref: RK-THT-BMC-3-10 |
00850033131093 - RegenKit Wound-Gel | 2024-03-20 . |
00850033131031 - RegenLab USA | 2023-05-08 |
00850033131048 - RegenLab USA | 2023-05-08 |
00850033131055 - RegenLab USA | 2023-05-08 |
00850033131062 - RegenLab USA | 2023-05-08 |
00850033131079 - RegenLab USA | 2023-05-08 |
00850033131086 - RegenLab USA | 2023-05-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
REGENKIT 79062709 3718804 Live/Registered |
RegenLab USA LLC 2008-09-19 |