Primary Device ID | D813LPMM0 |
NIH Device Record Key | 50aeaadd-6404-40a0-8449-746a832ad8a7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PeriOptix® |
Version Model Number | L-PPM |
Catalog Number | L-PPM |
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 | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D813LPMM0 [Primary] |
HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-09-30 |
Device Publish Date | 2022-09-22 |
D813LPMM0 | PUPILIOMETER |
D813AREPKITNA0 | PERIOPTIX REP KIT US/CN |
D813ALED60 | LUMIPRO HEADLIGHT SYSTEM |
D813ALED5R0 | FIREFLY UNIT RED |
D813ALED5B0 | FIREFLY UNIT BLUE |
D813ALED50 | FIREFLY UNIT |
D813200POPTIX0 | PERIOPTIX KIT ASSEMBLY |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PERIOPTIX 85799256 4354094 Live/Registered |
Den-Mat Holdings, LLC 2012-12-10 |