Primary Device ID | J0071700784001E1 |
NIH Device Record Key | 1a498463-bab6-40d4-aaf8-06fb69d87bbc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SET BIOPOWER |
Version Model Number | 1700784-001E |
Company DUNS | 480082080 |
Company Name | Bien-Air Dental SA |
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 | false |
Serial Number | true |
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 |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com | |
Phone | +1 949-477-6050 |
ba-usa@bienair.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | J0071700784001E1 [Primary] |
EBW | Controller, Foot, Handpiece And Cord |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-08 |
Device Publish Date | 2023-05-31 |
J00717007840011 | Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories |
J0071700784001E1 | Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories |