Primary Device ID | D8130303952500 |
NIH Device Record Key | d7e40719-a6e7-44ab-b10e-998bef984442 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sapphire® Plus |
Version Model Number | 030395250 |
Catalog Number | 030395250 |
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 | true |
OTC Over-The-Counter | false |
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 | D8130303952500 [Primary] |
EBZ | Activator, Ultraviolet, For Polymerization |
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 |
D813033968000L0 | LT SAPPHIRE PLUS LOANER |
D8130339680000 | LT SAPPHIRE PLUS |
D813033958000L0 | LT SAPPHIRE LOANER |
D8130339587010 | LT SAPH PLUS UPGRADE KIT |
D8130339585060 | LT SAPH 2mm TACKING TIP PKG |
D8130339585030 | LT SAPPHIRE 12mm TIP PKG |
D8130339585010 | LT SAPPHIRE 4mm TIP PKG |
D8130305991050 | DISPENSING GUN 25mL DCHMB SY |
D8130305972750 | LT SAPH ROLLING STAND W/ARM |
D8130305953750 | CRYSTAL ARM w/HLDR & PIVOT |
D8130303952500 | SAPH WHT CRYSTAL KIT |