Excalibur sterile 31mm E20-E45

GUDID 00810092939832

Blister of 4 units

NUSMILE, LTD.

Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use
Primary Device ID00810092939832
NIH Device Record Key2eebedb6-6b48-4b25-97c3-04cd7fe21972
Commercial Distribution StatusIn Commercial Distribution
Brand NameExcalibur sterile 31mm E20-E45
Version Model NumberZRE31ASST1
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
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
GS100810092939832 [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 Date2023-04-20
Device Publish Date2023-04-12

Devices Manufactured by NUSMILE, LTD.

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00810118104398 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1)
00810118104404 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS2)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS2)
00810118104411 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS3)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS3)
00810118104428 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1-ZS3)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1-ZS3)

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