X-Plorer™ Canal Navigation Files 15/.01 (25mm) 319001

GUDID 07540172014496

Endodontic surgical files

CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Rotary/reciprocating endodontic file/rasp, reusable
Primary Device ID07540172014496
NIH Device Record Keydd121ace-f325-455d-a819-2db5d32e4c31
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-Plorer™ Canal Navigation Files 15/.01 (25mm)
Version Model Number319001
Catalog Number319001
Company DUNS626406016
Company NameCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)265-3444
Email[email protected]

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS107540172014496 [Primary]

FDA Product Code

EKSFILE, PULP CANAL, ENDODONTIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07540172014496]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17