Primary Device ID | E23572100 |
NIH Device Record Key | 6214ffba-baaa-4cd6-b759-3c738cddbdd1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Vintage Halo |
Version Model Number | 7210 |
Catalog Number | 7210 |
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 | E23572100 [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 | 2016-09-25 |
E23579020 | HALO VALUE MINUS 15G VMODROOTR |
E23579010 | HALO VALUE MINUS 15G VMOD-R4 |
E23579000 | HALO VALUE MINUS 15G VMOD-R3.5 |
E23578990 | HALO VALUE MINUS 15G VMOD-R3 |
E23578980 | HALO VALUE MINUS 15G VMOD-R2 |
E23578970 | HALO VALUE MINUS 15G VMOD-R1 |
E23578960 | HALO VALUE MINUS 15G VMODROOTA |
E23578950 | HALO VALUE MINUS 15G VMOD-A4 |
E23578940 | HALO VALUE MINUS 15G VMOD-A3.5 |
E23578930 | HALO VALUE MINUS 15G VMOD-A3 |
E23578920 | HALO VALUE MINUS 15G VMOD-A2 |
E23578910 | HALO VALUE MINUS 15G VMOD-A1 |
E23578820 | VM ROOT R BODY 15g |
E23578810 | HALO VALUE MINUS 15G VMR4B |
E23578800 | HALO VALUE MINUS 15G VMR3.5B |
E23578790 | HALO VALUE MINUS 15G VMR3B |
E23578780 | HALO VALUE MINUS 15G VMR2B |
E23578770 | HALO VALUE MINUS 15G VMR1B |
E23578760 | HALO VALUE MINUS 15G VMROOTAB |
E23578750 | HALO VALUE MINUS 15G VMA4B |
E23578740 | HALO VALUE MINUS 15G VMA3.5B |
E23578730 | HALO VALUE MINUS 15G VMA3B |
E23578720 | HALO VALUE MINUS 15G VMA2B |
E23578710 | HALO VALUE MINUS 15G VMA1B |
E23578620 | HALO VALUE MINUS 15G VMR R0 |
E23578610 | HALO VALUE MINUS 15G VMR4O |
E23578600 | HALO VALUE MINUS 15G VMR3.5O |
E23578590 | HALO VALUE MINUS 15G VMR3O |
E23578580 | HALO VALUE MINUS 15G VMR2O |
E23578570 | HALO VALUE MINUS 15G VMR1O |
E23578560 | HALO VALUE MINUS 15G VMROOTAO |
E23578550 | HALO VALUE MINUS 15G VMA4O |
E23578540 | HALO VALUE MINUS 15G VMA3.5O |
E23578530 | HALO VALUE MINUS 15G VMA3O |
E23578520 | HALO VALUE MINUS 15G VMA20 |
E23578510 | HALO VALUE MINUS 15G VMA1O |
E23577880 | Vintage Halo Whitening 50g W3B |
E23577870 | Vintage Halo Whitening 50g W2B |
E23577860 | Vintage Halo Whitening 50g W1B |
E23577830 | Vintage Halo Whitening 15g W3B |
E23577820 | Vintage Halo Whitening 15g W2B |
E23577810 | Vintage Halo Whitening 15g W1B |
E23577780 | Vintage Halo Whitening 50g W30 |
E23577770 | Vintage Halo Whitening 50g W20 |
E23577760 | Vintage Halo Whitening 50g W10 |
E23577730 | Vintage Halo Whitening 15g W30 |
E23577720 | Vintage Halo Whitening 15g W20 |
E23577710 | Vintage Halo Whitening 15g W10 |
E23577700 | Vintage Halo Whitening Set |
E23577490 | HALO OPAQUE DENTIN 50G OD-D4 |