Primary Device ID | D813CR1079ABC0 |
NIH Device Record Key | ff52566f-cacd-499a-9b8e-ce6104422637 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MAGNA 4.0 |
Version Model Number | CR1079ABC |
Catalog Number | CR1079ABC |
Company DUNS | 809857704 |
Company Name | DEN-MAT HOLDINGS, LLC |
Device Count | 1 |
DM Exempt | true |
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 | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-800-4336628 |
info@denmat.com | |
Phone | 1-800-4336628 |
info@denmat.com |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D813CR1079ABC0 [Primary] |
EBZ | Activator, Ultraviolet, For Polymerization |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-09-28 |
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