Primary Device ID | 00850033131024 |
NIH Device Record Key | 1443dec6-4d45-43a3-8cce-77c16078d761 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Accessory Set |
Version Model Number | BCA-SET3-U |
Company DUNS | 087434117 |
Company Name | Regenlab USA LLC |
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 | 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 |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850033131024 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-12-02 |
Device Publish Date | 2021-11-24 |
08500331310035 | BCA-SET3-20 |
08500331310028 | BCA-SET3-U |
00850033131017 | BCA-SET3-20 |
00850033131024 | BCA-SET3-U |