Deflux Metal Needle

GUDID 00850004725023

Deflux Metal Needle

PALETTE LIFE SCIENCES, INC.

Submucosal injection needle
Primary Device ID00850004725023
NIH Device Record Key8c024a4e-a6eb-49b0-8d57-1ea470be0b8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDeflux Metal Needle
Version Model Number3.7 FR x 23 G (tip) x 350 mm
Company DUNS116951700
Company NamePALETTE LIFE SCIENCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-844-350-9656
Emailpalettemc@dlss.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com
Phone1-844-822-7744
Emailsupport@palettelifesciences.com

Device Dimensions

Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge
Length350 Millimeter
Needle Gauge23 Gauge

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004725023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMNCeramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses
LNMAgent, Bulking, Injectable For Gastro-Urology Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-11

Devices Manufactured by PALETTE LIFE SCIENCES, INC.

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00850004725115 - Barrigel Applicator Needle2022-12-08 Hypodermic needles for the injection of Barrigel
00850004725023 - Deflux Metal Needle2019-03-11Deflux Metal Needle
00850004725023 - Deflux Metal Needle2019-03-11 Deflux Metal Needle
00850004725009 - Deflux2019-03-04 Deflux
00850004725016 - Solesta2019-03-04 Solesta

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