Primary Device ID | D813PLS10010 |
NIH Device Record Key | 09d8e9e2-e8d7-4646-bb73-5c6710230086 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VIZILITE PRO |
Version Model Number | PLS1001 |
Catalog Number | PLS1001 |
Company DUNS | 809857704 |
Company Name | DEN-MAT HOLDINGS, 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 | false |
Lot Batch | false |
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 | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D813PLS10010 [Primary] |
NXV | Diagnostic Light, Soft Tissue Detector |
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 | 2016-11-14 |
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Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VIZILITE PRO 87295333 5368116 Live/Registered |
Den-Mat Holdings, LLC 2017-01-10 |