Deflux

GUDID 00850004725009

Deflux

PALETTE LIFE SCIENCES, INC.

Urinary tract reconstructive material, microbe-derived
Primary Device ID00850004725009
NIH Device Record Keyec9f441b-b08f-4712-bb2e-9f2ed18b1d7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDeflux
Version Model NumberGel 1.0 mL Syringe
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

Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004725009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2019-03-04
Device Publish Date2019-02-01

Devices Manufactured by PALETTE LIFE SCIENCES, INC.

00850004725139 - Barrigel2023-03-09 Barrigel convenience kit
00850004725108 - Barrigel2022-12-08 Hydrogel (HA) Injectable Rectal Spacer
00850004725115 - Barrigel Applicator Needle2022-12-08 Hypodermic needles for the injection of Barrigel
00850004725023 - Deflux Metal Needle2019-03-11 Deflux Metal Needle
00850004725009 - Deflux2019-03-04Deflux
00850004725009 - Deflux2019-03-04 Deflux
00850004725016 - Solesta2019-03-04 Solesta

Trademark Results [Deflux]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DEFLUX
DEFLUX
77118595 3458947 Live/Registered
NESTLÉ SKIN HEALTH S.A.
2007-02-28
DEFLUX
DEFLUX
75505567 2274215 Live/Registered
NESTLÉ SKIN HEALTH S.A.
1998-06-19

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