FDA UDI In Commercial Distribution 🇺🇸 United States

BEYOND® II Ultra Whitening Accelerator

DI: 00857848007728 · Model: BE-818UL · Beyond International Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BEYOND® II Ultra Whitening Accelerator
Primary DI
00857848007728
Version / Model
BE-818UL
Company Name
Beyond International Inc.
Labeler DUNS
080721790
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-23
Public Version
1
Public Version Date
2023-01-02
Public Version Status
New
Public Device Record Key
2ad05082-7a29-4388-967e-cc2efcec6f8c

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
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
EEG Heat Source For Bleaching Teeth

GMDN Terms

Code Name
31806 Tooth-bleaching acceleration unit

Identifiers

Type ID
Primary 00857848007728