FDA UDI In Commercial Distribution 🇺🇸 United States

Console Chiropro PLUS 3rd Gen.

DI: J00716009940011 · Model: 1600994-001 · Bien-Air Dental SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Console Chiropro PLUS 3rd Gen.
Primary DI
J00716009940011
Version / Model
1600994-001
Catalog Number
1600994-001
Company Name
Bien-Air Dental SA
Labeler DUNS
480082080
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-17
Public Version
1
Public Version Date
2021-06-25
Public Version Status
New
Public Device Record Key
56fa48ef-2d7a-4453-adaf-cd5b7d1dacb7

Device Description

Chiropro are electrical medical devices used to run dental instruments

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EBW Controller, foot, handpiece and cord

GMDN Terms

Code Name
41264 Surgical power tool system control unit, line-powered

Identifiers

Type ID
Primary J00716009940011

Customer Contacts