FDA UDI In Commercial Distribution 🇺🇸 United States

Demi Plus

DI: 00841396101656 · Model: 910860-1 · Kerr Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Demi Plus
Primary DI
00841396101656
Version / Model
910860-1
Catalog Number
910860-1
Company Name
Kerr Corporation
Labeler DUNS
199354556
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-12
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
36471079-1586-47bf-8170-997ecf0ae272

Device Description

LED Light Curing System 120V

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
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
Primary 00841396101656

Customer Contacts

Phone
+18005377123

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Store at Temperature -4F to 104F Humidity 10% to 85%; Atmospheric Pressure 0.5 atm to 1.0 atm