FDA UDI In Commercial Distribution 🇺🇸 United States

Premium Plus

DI: D838CS3399105RL2 · Model: CS3399-105RL · Premium Plus International Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
Premium Plus
Primary DI
D838CS3399105RL2
Version / Model
CS3399-105RL
Company Name
Premium Plus International Limited
Labeler DUNS
668367758
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2020-01-03
Public Version
1
Public Version Date
2020-01-13
Public Version Status
New
Public Device Record Key
70fc9171-7195-4933-93fd-82f077876472

Device Description

Disposable Prophy Angles

Device Characteristics

Single Use
Yes
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
No
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
EGS Handpiece, Contra- And Right-Angle Attachment, Dental

GMDN Terms

Code Name
46938 Dental polishing cup, single-use

Identifiers

Type ID
Package D838CS3399105RL8
Primary D838CS3399105RL2
Unit of Use D838CS3399105RL0