FDA UDI In Commercial Distribution 🇺🇸 United States

Handpiece SA-40 L with cable 3.5 m

DI: J021303920011 · Model: 30392001 · W & H Dentalwerk Bürmoos GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Handpiece SA-40 L with cable 3.5 m
Primary DI
J021303920011
Version / Model
30392001
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
2022-10-19
Public Version
1
Public Version Date
2022-10-27
Public Version Status
New
Public Device Record Key
d808b359-30b9-43a8-a012-5a841a8aaa23

Device Description

Piezomed Accessory

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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
DZI Drill, Bone, Powered
ELC Scaler, Ultrasonic

GMDN Terms

Code Name
47010 Dental ultrasonic surgical system

Identifiers

Type ID
Direct Marking J021303920010
Primary J021303920011