FDA.reportPublic FDA data

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#

Product Codes#

Code, Name table
CodeName
OVBHydrogel Spacer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVBHydrogel SpacerRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220641000Barrigel Injectable GelPalette Life Sciences2022-05-26OVB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004725115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004725115008500047251158500047251150850004725115

GMDN Terms#

Term, Definition table
TermDefinition
Radiotherapy protection spacerA sterile, bioabsorbable material (e.g., liquid or gel) intended to be injected between the prostate and the rectum prior to radiotherapy of the prostate, to increase the distance between the prostate and the anterior rectal wall, thereby reducing exposure of the rectum to radiation. It is typically comprised of hyaluronic acid (HA) and may be available in a prefilled syringe. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Centimeter
Needle Gauge18Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit25 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8058967087dgoodnough@palettelifesciences.com
1-844-822-7744support@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 DIBrandModelCatalogPublished
00850004725139Barrigel3016-13016-12023-03-01
00850004725108Barrigel0115080115082022-11-30
00850004725009DefluxGel 1.0 mL Syringe0115042019-02-01
00850004725016SolestaGel 1.0 mL Syringe0115062019-02-01
00850004725023Deflux Metal Needle3.7 FR x 23 G (tip) x 350 mmDX12012019-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290014878020BioProtect Balloon Implant™ SystemBIOPROTECT LTDOVB2023-11-03
00850004725139BarrigelPALETTE LIFE SCIENCES, INC.OVB2023-03-01
00850004725108BarrigelPALETTE LIFE SCIENCES, INC.OVB2022-11-30
00864661000140SpaceOAR VUE™ System - 10mLBOSTON SCIENTIFIC CORPORATIONOVB2019-10-01
00864661000102SpaceOAR SystemBOSTON SCIENTIFIC CORPORATIONOVB2015-12-10