Primary Device ID | D8130562005350 |
NIH Device Record Key | 4c1e4370-bbfc-4bc3-8f2c-6f8c978d8e92 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ORTHOCLEAR - PL VAKT |
Version Model Number | 056200535 |
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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
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 | |
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 | |
Phone | 1-800-433-6628 |
info@denmat.com |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D8130562005350 [Primary] |
NXC | Aligner, Sequential |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-03-14 |
Device Publish Date | 2023-03-06 |
D8130398114010 - TENURE | 2024-05-16 TENURE MPB SYSTEM BAG |
D8130398140000 - TENURE | 2024-05-16 TENURE 4G SAMPLE PACK |
D813444000L0 - CCD BLUEWAVE LASER | 2023-10-18 CCD LASER WIRELESS LOANER |
D8130561006970 - VAKT | 2023-04-26 VAKT ALIGNER UPR & LWR |
D8130303761050 - GBLOCK | 2023-03-14 GBLOCK DESENSITIZER 5ml |
D8130303761100 - GBLOCK | 2023-03-14 GBLOCK DESENSITIZER 10ml |
D8130562005300 - VAKT PRIVATE LABEL | 2023-03-14 VAKT ALIGNER UPPER |
D8130562005350 - ORTHOCLEAR - PL VAKT | 2023-03-14VAKT ALIGNER LOWER |
D8130562005350 - ORTHOCLEAR - PL VAKT | 2023-03-14 VAKT ALIGNER LOWER |