Avalon Biomed by Zarc BlueShaper PRO sterile File 31mm ZXS-Z5

GUDID 00810118105623

Avalon Biomed by Zarc BlueShaper PRO sterile File 31mm ZXS-Z5 (6 units)

NUSMILE, LTD.

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device ID00810118105623
NIH Device Record Keyf8299f29-0f76-499e-b385-7e1aaa093ff3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvalon Biomed by Zarc BlueShaper PRO sterile File 31mm ZXS-Z5
Version Model NumberZBS31APROS
Company DUNS185497372
Company NameNUSMILE, LTD.
Device Count1
DM Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118105623 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-18
Device Publish Date2025-03-10

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