FDA UDI In Commercial Distribution 🇺🇸 United States

Bluephase G4

DI: 07615208458251 · Model: 691267BU · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Bluephase G4
Primary DI
07615208458251
Version / Model
691267BU
Catalog Number
691267BU
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-11-21
Public Version
1
Public Version Date
2022-11-29
Public Version Status
New
Public Device Record Key
1af8649e-258a-4147-9b1a-f06c48b71c00

Device Description

Bluephase G4 100-240V pink & Radiometer

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
EBZ ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

GMDN Terms

Code Name
35775 Dental/surgical polymerization lamp

Identifiers

Type ID
Direct Marking 07615208461640
Primary 07615208458251
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