Primary Device ID | D6919011100 |
NIH Device Record Key | 9cf4fbde-0f8e-4815-9dca-902d6559c70d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Brite Shield |
Version Model Number | 9011100 |
Company DUNS | 014789663 |
Company Name | PREMIER DENTAL PRODUCTS COMPANY |
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 | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D6919011100 [Primary] |
FLG | Cleaner, Ultrasonic, Medical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-07 |
Device Publish Date | 2022-06-29 |
D6919011997 | Brite Shield 10 Pack |
D6919011996 | BRITE SHIELD SAMPLE (1pk) |
D6919011950 | CLEANER SAMPLE PACK (BS/VA) |
D6919011911 | Brite Shield Sample INTL w/Illustration Card |
D6919011100 | BRITE SHIELD (CASE OF 6) |
00348783003789 | BRITE SHIELD (Single Jar) |
00348783003819 | CLEANER SAMPLE PACK (BS/VA) |
00348783003802 | Brite Shield Sample INTL w/Illustration Card |
00348783003796 | BRITE SHIELD (CASE OF 6) |
00348783000672 | BRITE SHIELD SAMPLE (1pk) |