Flex Flo Tips 2 units

GUDID 00810118101199

Flex Flo Tips 2 units

NUSMILE, LTD.

Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use
Primary Device ID00810118101199
NIH Device Record Keyea7f10d5-7df5-481c-aa50-92d24390b169
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlex Flo Tips 2 units
Version Model NumberZFFT02
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118101199 [Primary]

FDA Product Code

EICSyringe, Periodontic, Endodontic, Irrigating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-29
Device Publish Date2023-03-21

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.