Primary Device ID | D813ZLR20080 |
NIH Device Record Key | 34f7188c-5a8a-4161-8851-476b7d69b979 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SL3® |
Version Model Number | ZLR2008 |
Catalog Number | ZLR2008 |
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 | D813ZLR20080 [Primary] |
GEX | Powered Laser Surgical Instrument |
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 |
D813ZLR2006A1 | SL3 DISP PERIO TIPS 7MM 25PK |
D813ZLR2005A1 | SL3 DISP REG TIPS 5MM 25PK |
D813ZLR20040 | SL3 FOOT PEDAL |
D813ZLR20090 | SL3 REPLACEMENT POWER SUPPLY |
D813ZLR20080 | SL3 HANDPIECE AUTOCLAVABLE |
D813ZLR20030 | SL3 UNIFIBER SYSTEM |
D813ZLR10180 | FIBERS AC-FIBER 400um 12FT |