Primary Device ID | E235BBR0 |
NIH Device Record Key | 6ad17807-5bc6-4202-a069-fde9f0d1e32b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Beautifil |
Version Model Number | 001 |
Catalog Number | BBR |
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 | true |
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 |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E235BBR0 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-09-10 |
Device Publish Date | 2018-08-09 |
E235BBR0 | Beautifil Bulk Restorattive Tips Sample Kit. Contains DI's: E23520320, E23520330 |
E23514840 | BEAUTIFIL NEEDLE TIPS |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BEAUTIFIL 76306668 2563704 Live/Registered |
SHOFU, INC. 2001-08-30 |