Barrigel 3016-1

GUDID 00850004725139

Barrigel convenience kit

PALETTE LIFE SCIENCES, INC.

Radiotherapy protection spacer
Primary Device ID00850004725139
NIH Device Record Keye1e77575-a12a-4627-8cf8-207844f722ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameBarrigel
Version Model Number3016-1
Catalog Number3016-1
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 Kittrue
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

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 Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter

Operating and Storage Conditions

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
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing and sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004725139 [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 Date2023-03-09
Device Publish Date2023-03-01

On-Brand Devices [Barrigel]

00850004725108Hydrogel (HA) Injectable Rectal Spacer
00850004725139Barrigel convenience kit

Trademark Results [Barrigel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BARRIGEL
BARRIGEL
98135710 not registered Live/Pending
GALDERMA HOLDING S.A.
2023-08-16
BARRIGEL
BARRIGEL
97675590 not registered Live/Pending
Galderma Holding SA
2022-11-14
BARRIGEL
BARRIGEL
90581707 not registered Live/Pending
Galderma Holding SA
2021-03-16
BARRIGEL
BARRIGEL
88710466 not registered Live/Pending
Nestlé Skin Health S.A.
2019-11-29
BARRIGEL
BARRIGEL
87796309 not registered Dead/Abandoned
Nestlé Skin Health S.A.
2018-02-13
BARRIGEL
BARRIGEL
86781067 not registered Dead/Abandoned
GALDERMA S.A.
2015-10-07
BARRIGEL
BARRIGEL
86031059 not registered Dead/Abandoned
GALDERMA S.A.
2013-08-07

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