Barrigel Applicator Needle

GUDID 00850004725115

Hypodermic needles for the injection of Barrigel

PALETTE LIFE SCIENCES, INC.

Radiotherapy protection spacer
Primary Device ID00850004725115
NIH Device Record Key6f02f7dc-f420-4443-8df9-1553e919f883
Commercial Distribution StatusIn Commercial Distribution
Brand NameBarrigel Applicator Needle
Version Model Number3009-2
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 Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8058967087
Emaildgoodnough@palettelifesciences.com
Phone8058967087
Emaildgoodnough@palettelifesciences.com
Phone8058967087
Emaildgoodnough@palettelifesciences.com
Phone8058967087
Emaildgoodnough@palettelifesciences.com
Phone8058967087
Emaildgoodnough@palettelifesciences.com
Phone8058967087
Emaildgoodnough@palettelifesciences.com
Phone8058967087
Emaildgoodnough@palettelifesciences.com
Phone8058967087
Emaildgoodnough@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
Phone1-844-822-7744
Emailsupport@palettelifesciences.com

Device Dimensions

Length20 Centimeter
Length20 Centimeter
Length20 Centimeter
Length20 Centimeter
Length20 Centimeter
Length20 Centimeter
Length20 Centimeter
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter
Needle Gauge18 Gauge
Length20 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 25 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004725115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVBHydrogel Spacer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

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

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