Barrigel Applicator Needle

Primary DI: 00850004725115
Brand: Barrigel Applicator Needle
Company: PALETTE LIFE SCIENCES, INC.
Model: 3009-2
Catalog number: 3009-2
Device description: Barrigel applicator needle
Published: 2022-11-30
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
Sterile: true
Single use: true

Contact Domains#

palettelifesciences.com

Product Codes#

Code, Name table
Code	Name
OVB	Hydrogel Spacer

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
OVB	Hydrogel Spacer	Radiology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K220641	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K220641	000	Barrigel Injectable Gel	Palette Life Sciences	2022-05-26	OVB

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00850004725115	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00850004725115	00850004725115	850004725115	0850004725115

Device Sizes#

Type, Value, Unit table
Type	Value	Unit
Length	20	Centimeter
Needle Gauge	18	Gauge

Storage And Handling#

Type, Low, High table
Type	Low	High	Condition
Storage Environment Temperature	0 Degrees Fahrenheit	25 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
Phone	Email
8058967087	dgoodnough@palettelifesciences.com
1-844-822-7744	support@palettelifesciences.com

Regulatory Flags#

DUNS number: 116951700
Device count: 1
Lot or batch: true
Expiration date on label: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00850004725139	Barrigel	3016-1	3016-1	2023-03-01
00850004725108	Barrigel	011508	011508	2022-11-30
00850004725009	Deflux	Gel 1.0 mL Syringe	011504	2019-02-01
00850004725016	Solesta	Gel 1.0 mL Syringe	011506	2019-02-01
00850004725023	Deflux Metal Needle	3.7 FR x 23 G (tip) x 350 mm	DX1201	2019-02-11

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
07290014878020	BioProtect Balloon Implant™ System	BIOPROTECT LTD	OVB	2023-11-03
00850004725139	Barrigel	PALETTE LIFE SCIENCES, INC.	OVB	2023-03-01
00850004725108	Barrigel	PALETTE LIFE SCIENCES, INC.	OVB	2022-11-30
00864661000140	SpaceOAR VUE™ System - 10mL	BOSTON SCIENTIFIC CORPORATION	OVB	2019-10-01
00864661000102	SpaceOAR System	BOSTON SCIENTIFIC CORPORATION	OVB	2015-12-10