| Primary Device ID | D8130313375200 |
| NIH Device Record Key | 97296a87-a22d-4c21-bec0-224c9e596b29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ceri-Sander™ |
| Version Model Number | 031337520 |
| Catalog Number | 031337520 |
| 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 | D8130313375200 [Unit of Use] |
| HIBCC | D8130313375201 [Primary] |
| DZN | Instruments, Dental Hand |
| 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 |