FDA UDI In Commercial Distribution 🇺🇸 United States

ISSA™ mini 2

DI: 07350092138451 · Model: MANGO TANGO · Foreo AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ISSA™ mini 2
Primary DI
07350092138451
Version / Model
MANGO TANGO
Company Name
Foreo AB
Labeler DUNS
352394143
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-05-26
Public Version
1
Public Version Date
2022-06-03
Public Version Status
New
Public Device Record Key
0439b496-5298-414e-a804-1295746de3d1

Device Description

ISSA™ mini 2 is a powered toothbrush, an ideal choice if you prefer the benefits of a silicone sonic toothbrush, just more compact - it’s medical-grade, ultra-hygienic & 100% waterproof, with up to 9,000 sonic pulsations per minute. No need to worry about charging - get up to 265 uses per one USB charge.

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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JEQ Toothbrush, Powered

GMDN Terms

Code Name
43090 Basic electric toothbrush

Identifiers

Type ID
Primary 07350092138451