SOL® LR1008

GUDID D813LR10080

LASER EYEWEAR

DEN-MAT HOLDINGS, LLC

Radiation shielding goggles/spectacles
Primary Device IDD813LR10080
NIH Device Record Keyc2dfa3c5-8dd5-4389-9098-6ed1594340cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOL®
Version Model NumberLR1008
Catalog NumberLR1008
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD813LR10080 [Primary]

FDA Product Code

HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-30
Device Publish Date2022-09-22

On-Brand Devices [SOL®]

D813LR10450KT SOL WIRELESS UPGRADE
D813LR10101SOL/SAPH ASSY 300um TIP 25pc
D813LR10040SOL FOOT PEDAL ASSY
D813LR1001WL0SOL WIRELESS LOANER
D813LR1001W0SOL LASER SYSTEM INTG WIRELESS
D813LR1001L0SOL LASER SYSTEM INTG LOANER
D813LR1001DW0SOL LASER INTG WIRELESS-DEALER
D813LR100060SOL HANDPIECE REPLACEMENT KIT
D81303398002801SOL/SAPH LSR 400um TIPS 25pc
D813LR1008CCD0CC LASER SAFETY GLASSES
D813LR10080LASER EYEWEAR
D813LR1001WINT0SOL INTEGRATED WIRLESS IT

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