FDA UDI In Commercial Distribution 🇺🇸 United States

Premium Plus

DI: D8387460B4 · Model: 7460-B · Premium Plus International Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Premium Plus
Primary DI
D8387460B4
Version / Model
7460-B
Company Name
Premium Plus International Limited
Labeler DUNS
668367758
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-12-27
Public Version
2
Public Version Date
2023-05-04
Public Version Status
Update
Public Device Record Key
b28f21c5-7e89-415d-ae9d-ab1077fac215

Device Description

MIXING BOWLS

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JDZ Mixer, Cement, For Clinical Use

GMDN Terms

Code Name
63877 Dental material mixing surface, chairside, reusable

Identifiers

Type ID
Package D8387460B8
Package D8387460B6
Primary D8387460B4