Primary Device ID | E23589840 |
NIH Device Record Key | a4a1de40-2c8a-49a5-91d2-ab5bdf6323d1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Vintage ZR Press Over |
Version Model Number | 8984 |
Catalog Number | 8984 |
Company DUNS | 054618202 |
Company Name | SHOFU DENTAL CORPORATION |
Device Count | 1 |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 760-566-3528 |
ckaemmerlen@shofu.com |
Handling Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E23589840 [Primary] |
EIH | Powder, Porcelain |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-24 |
Device Publish Date | 2016-09-24 |
E23589870 | VINTAGE ZR PRESS OVER N |
E23589860 | VINTAGER ZR PRESS OVER W3 |
E23589850 | VINTAGE ZR PRESS OVER W2 |
E23589840 | VINTAGER ZR PRESS OVER W1 |
E23589830 | VINTAGE ZR PRESS OVER D3 |
E23589820 | VINTAGE ZR PRESS OVER D2 |
E23589800 | VINTAGE ZR PRESS OVER C2 |
E23589790 | VINTAGE ZR PRESS OVER C1 |
E23589760 | VINTAGE ZR PRESS OVER B2 |
E23589750 | VINTAGE ZR PRESS OVER B1 |
E23589730 | VINTAGE ZR PRESS OVER A3.5 |
E23589720 | VINTAGE ZR PRESS OVER A3 |
E23589710 | VINTAGE ZR PRESS OVER A2 |
E23589700 | VINTAGE ZR PRESS OVER A1 |