FDA UDI In Commercial Distribution 🇺🇸 United States

ProUltra PiezoFlow

DI: D716PIEZOFLOWREFILL1 · Model: PIEZOFLOWREFILL · TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24

Basic Information

Brand Name
ProUltra PiezoFlow
Primary DI
D716PIEZOFLOWREFILL1
Version / Model
PIEZOFLOWREFILL
Catalog Number
PIEZOFLOWREFILL
Company Name
TULSA DENTAL PRODUCTS LLC
Labeler DUNS
942778564
Distribution Status
In Commercial Distribution
Device Count in Pkg
24
Record Status
Published
Publish Date
2022-10-18
Public Version
1
Public Version Date
2022-10-26
Public Version Status
New
Public Device Record Key
e18ca0f3-3e3b-4f2c-9e08-992348919e62

Device Description

PiezoFlow Refill Pack

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

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Liquid Chemical

Product Codes

Code Name
ELC Scaler, ultrasonic

GMDN Terms

Code Name
63814 Root canal ultrasonic irrigation handpiece tip

Identifiers

Type ID
Unit of Use D716PIEZOFLOWREFILL0
Primary D716PIEZOFLOWREFILL1