FDA UDI In Commercial Distribution 🇺🇸 United States

EXP-PD-ST-00 (Pump Controller)

DI: J021303630001 · Model: 30363000 · W & H Dentalwerk Bürmoos GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
EXP-PD-ST-00 (Pump Controller)
Primary DI
J021303630001
Version / Model
30363000
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
2023-07-19
Public Version
1
Public Version Date
2023-07-27
Public Version Status
New
Public Device Record Key
d3d79890-ff99-4e84-a690-576575c88c28

Device Description

Built-in Component

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
EIA Unit, Operative Dental
ELC Scaler, Ultrasonic

GMDN Terms

Code Name
60930 Dental delivery system instrument unit, electric

Identifiers

Type ID
Direct Marking J021303630000
Primary J021303630001