FDA UDI In Commercial Distribution 🇺🇸 United States

Vivid KleenSert

DI: D724R9101160 · Model: R910116 · PEARSON DENTAL SUPPLIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Vivid KleenSert
Primary DI
D724R9101160
Version / Model
R910116
Company Name
PEARSON DENTAL SUPPLIES, INC.
Labeler DUNS
082874108
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-06-29
Public Version
3
Public Version Date
2019-02-21
Public Version Status
Update
Public Device Record Key
58e2aa47-690a-41ab-95d3-5dfede581ff8

Device Description

P-100 30k

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
ELC Scaler, Ultrasonic

GMDN Terms

Code Name
46035 Ultrasonic dental scaling/debridement system handpiece tip, endodontic

Identifiers

Type ID
Primary D724R9101160