Primary Device ID | H66809210741 |
NIH Device Record Key | 1be6667f-db5d-4b3c-9567-abd87ca0cad3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bosworth Hydrox |
Version Model Number | 0921074 |
Catalog Number | 0921074 |
Company DUNS | 014769301 |
Company Name | Harry J Bosworth Company |
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 | 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 | +1(800)333-3131 |
tschwear@keystoneind.com |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
HIBCC | H66809210741 [Primary] |
EJK | LINER, CAVITY, CALCIUM HYDROXIDE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-15 |
H66809210741 | Cavity Liner 6 pk Base & Catalyst Dentin Kit |
H66809210731 | Cavity Liner 6 pk Base & Catalyst Ivory Kit |
H66809210721 | Cavity Liner Base & Catalyst Ivory Kit |
H66809210711 | Cavity Liner Base & Catalyst Dentin Kit |