FDA UDI In Commercial Distribution 🇺🇸 United States

BLUEPHASE STYLE

DI: DVIV6494181 · Model: 649418 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
BLUEPHASE STYLE
Primary DI
DVIV6494181
Version / Model
649418
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-01-29
Public Version
2
Public Version Date
2022-02-07
Public Version Status
Update
Public Device Record Key
65a095df-e543-4ff1-b08f-4317cb85d7c7

Device Description

Bluephase Style handpiece light blue

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
No
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
EBZ ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

GMDN Terms

Code Name
35775 Dental/surgical polymerization lamp

Identifiers

Type ID
Primary DVIV6494181