Primary Device ID | 00847627035486 |
NIH Device Record Key | 85e75a20-535d-4705-a37b-135ef42f2dcf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dewax Solution 1, DS1 |
Version Model Number | OPRI6001KT60 |
Company DUNS | 806617825 |
Company Name | BIOCARE MEDICAL 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 | false |
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 Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00847627035486 [Primary] |
PPM | General Purpose Reagent |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-09 |
Device Publish Date | 2023-09-29 |
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