FDA UDI In Commercial Distribution 🇺🇸 United States

EM-19 LC

DI: J021302810011 · Model: 30281001 · W & H Dentalwerk Bürmoos GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
EM-19 LC
Primary DI
J021302810011
Version / Model
30281001
Company Name
W & H Dentalwerk Bürmoos GmbH
Labeler DUNS
300238441
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-29
Public Version
2
Public Version Date
2023-06-29
Public Version Status
Update
Public Device Record Key
b8ec80a5-c9e2-4d44-b2dc-e5fa9217ed17

Device Description

Electric Motor with cable 3.5m

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
Yes
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
66227 Dental surgical power tool motor, electric

Identifiers

Type ID
Direct Marking J021302810010
Primary J021302810011