FDA UDI In Commercial Distribution 🇺🇸 United States

BioSonic

DI: D661UC3151150 · Model: UC315115 · COLTENE/WHALEDENT INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BioSonic
Primary DI
D661UC3151150
Version / Model
UC315115
Company Name
COLTENE/WHALEDENT INC
Labeler DUNS
622185718
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-02-11
Public Version
2
Public Version Date
2023-09-18
Public Version Status
Update
Public Device Record Key
5ed57072-ad91-4251-ae49-f80ed5d7e38a

Device Description

Remote Digital Timer - UC300R

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
Yes
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
FLG Cleaner, Ultrasonic, Medical Instrument

GMDN Terms

Code Name
36749 Ultrasonic-cleaning water bath

Identifiers

Type ID
Primary D661UC3151150