Primary Device ID | D813LR10101 |
NIH Device Record Key | 110170d7-16c4-4806-900b-3889e0144567 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SOL® |
Version Model Number | LR1010 |
Catalog Number | LR1010 |
Company DUNS | 809857704 |
Company Name | DEN-MAT HOLDINGS, LLC |
Device Count | 25 |
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 | 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 |
Length | 400 Micrometer |
Length | 400 Micrometer |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D813LR10100 [Unit of Use] |
HIBCC | D813LR10101 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-11-08 |
Device Publish Date | 2016-09-24 |
D813LR10450 | KT SOL WIRELESS UPGRADE |
D813LR10101 | SOL/SAPH ASSY 300um TIP 25pc |
D813LR10040 | SOL FOOT PEDAL ASSY |
D813LR1001WL0 | SOL WIRELESS LOANER |
D813LR1001W0 | SOL LASER SYSTEM INTG WIRELESS |
D813LR1001L0 | SOL LASER SYSTEM INTG LOANER |
D813LR1001DW0 | SOL LASER INTG WIRELESS-DEALER |
D813LR100060 | SOL HANDPIECE REPLACEMENT KIT |
D81303398002801 | SOL/SAPH LSR 400um TIPS 25pc |
D813LR1008CCD0 | CC LASER SAFETY GLASSES |
D813LR10080 | LASER EYEWEAR |
D813LR1001WINT0 | SOL INTEGRATED WIRLESS IT |