Primary Device ID | D813ALED420 |
NIH Device Record Key | 17f09ab3-4db2-44ac-88e2-8b7dca9153e8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PeriOptix |
Version Model Number | A-LED4-2 |
Company DUNS | 809857704 |
Company Name | DEN-MAT HOLDINGS, 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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D813ALED420 [Primary] |
KYT | Light, Examination, Medical, Battery Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-09-27 |
Device Publish Date | 2024-09-19 |
D813ALED6990 | Lumipro Headlight System International |
D813ALED599R0 | Firefly Cordless Headlight System International Red |
D813ALED599B0 | Firefly Cordless Headlight system Internatinal Blue |
D813ALED5990 | Firefly Cordless Headlight System International |
D813ALED420 | MicroLine Mini Headlight System |
D813ALED41INT0 | MicroLine Mini Headlight System International |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PERIOPTIX 85799256 4354094 Live/Registered |
Den-Mat Holdings, LLC 2012-12-10 |