Primary Device ID | D8130313375100 |
NIH Device Record Key | 3bace851-b97c-459c-8fb6-537f0ba49d9c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ceri-Sander™ |
Version Model Number | 031337510 |
Catalog Number | 031337510 |
Company DUNS | 809857704 |
Company Name | DEN-MAT HOLDINGS, LLC |
Device Count | 6 |
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 | D8130313375100 [Unit of Use] |
HIBCC | D8130313375101 [Primary] |
DZB | Headgear, Extraoral, Orthodontic |
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 |
D8130313475200 | C-SNDR POST STRIPS UFINE 6pcSM |
D8130313475100 | C-SNDR POST STRIPS FINE 6pc SM |
D8130313475000 | CERISNDR POSTERIOR KIT w/STRPS |
D8130313375200 | CERISANDER STRIPS U-FINE 6pcLG |
D8130313375100 | CERISANDER STRIPS FINE 6pc LG |
D8130313375000 | CERISNDER ANTERIOR KIT w/STRPS |