Primary Device ID | D701BRL2 |
NIH Device Record Key | fb4cf91e-3cb6-4120-87d3-e88bda5edde5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Brush Tips and Handles |
Version Model Number | BRL |
Company DUNS | 001006089 |
Company Name | PULPDENT 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 | true |
Lot Batch | false |
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 | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D701BRL2 [Primary] |
KXR | Applicator, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-30 |
Device Publish Date | 2021-09-22 |
D701BR2L2 | Long Handle Brushes, 2 1/8 length, bag of 400 |
D701BR22 | Long Handle Brushes, 2 1/8 length, bag of 50 |
D701BR2 | Brush Tips, 24 mm length, bag of 100 |
D701HAN2 | Brush Handle (random color), 5” length |
D701BRL2 | Brush Tips, 24 mm length, bag of 500 + 2 Handles |