| Primary Device ID | E235093510 |
| NIH Device Record Key | ddd32086-b0de-4c8f-a43a-1267e0a567e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FG HYBRID T&F |
| Version Model Number | 0935-1 |
| Catalog Number | 0935-1 |
| Company DUNS | 054618202 |
| Company Name | SHOFU DENTAL CORPORATION |
| 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 | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E235093510 [Primary] |
| DZP | INSTRUMENT, DIAMOND, DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
[E235093510]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-11 |
| Device Publish Date | 2021-02-03 |
| E235094110 | FG HYBRID T&F |
| E23509410 | FG HYBRID T&F |
| E235093910 | FG HYBRID T&F |
| E235093710 | FG HYBRID T&F |
| E235093510 | FG HYBRID T&F |
| E235093310 | FG HYBRID T&F |
| E235093110 | FG HYBRID T&F |
| E235092910 | FG HYBRID T&F |
| E235092710 | FG HYBRID T&F |
| E235092510 | FG HYBRID T&F |
| E235094310 | FG HYBRID T&F |