Avalon Biomed NeoPUTTY 0.65 g Kit - SAMPLE

GUDID 00810118103810

A paste product designed for endodontic surgery or perforations, and vital pulp therapy.

NUSMILE, LTD.

Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement
Primary Device ID00810118103810
NIH Device Record Key5b4b7248-c647-4ca5-acc7-5e519702c6a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvalon Biomed NeoPUTTY 0.65 g Kit - SAMPLE
Version Model NumberSANPSK
Company DUNS185497372
Company NameNUSMILE, LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Device Dimensions

Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118103810 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-30
Device Publish Date2023-11-22

Devices Manufactured by NUSMILE, LTD.

00810118104350 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1)
00810118104367 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS2)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS2)
00810118104374 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS3)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS3)
00810118104381 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3)
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)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.