FDA UDI In Commercial Distribution 🇺🇸 United States

AM-16 RQ Airmotor

DI: J021304810001 · Model: 30481000 · W & H Dentalwerk Bürmoos GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
AM-16 RQ Airmotor
Primary DI
J021304810001
Version / Model
30481000
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
2023-07-11
Public Version
1
Public Version Date
2023-07-19
Public Version Status
New
Public Device Record Key
c3f161b1-3a43-4e13-bda9-27aa928251ac

Device Description

Air Motor

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
EFB Handpiece, Air-Powered, Dental

GMDN Terms

Code Name
66228 Dental surgical power tool motor, pneumatic

Identifiers

Type ID
Direct Marking J021304810000
Primary J021304810001