FDA.reportPublic FDA data

Deflux Metal Needle

Primary DI
00850004725023
Brand
Deflux Metal Needle
Company
PALETTE LIFE SCIENCES, INC.
Model
3.7 FR x 23 G (tip) x 350 mm
Catalog number
DX1201
Device description
Deflux metal needle
Published
2019-02-11
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
LMNCeramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses
LNMAgent, Bulking, Injectable For Gastro-Urology Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMNCeramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing UsesUnknown3
LNMAgent, Bulking, Injectable For Gastro-Urology UseUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000029084

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000029084DEFLUX INJECTABLE GELPalette Life Sciences2001-09-24LNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004725023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004725023008500047250238500047250230850004725023

GMDN Terms#

Term, Definition table
TermDefinition
Submucosal injection needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used in conjunction with a syringe to administer substances (e.g., fluids, gels) into the submucosal layer of tissue (connective tissue layer beneath the mucosa), typically of anatomical structures with lumens. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length350Millimeter
Needle Gauge23Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-350-9656palettemc@dlss.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
00850004725115Barrigel Applicator Needle3009-23009-22022-11-30
00850004725009DefluxGel 1.0 mL Syringe0115042019-02-01
00850004725016SolestaGel 1.0 mL Syringe0115062019-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810235030645CoaptiteMERZ NORTH AMERICA, INC.LNM2024-10-15
10810005340509BulkamidAXONICS MODULATION TECHNOLOGIES, INC.LNM2023-09-12
10810005340493BulkamidAXONICS MODULATION TECHNOLOGIES, INC.LNM2023-08-30
05704101500500BulkamidContura International A/SLNM2020-03-10
00850004725009DefluxPALETTE LIFE SCIENCES, INC.LNM2019-02-01
00850004725016SolestaPALETTE LIFE SCIENCES, INC.LNM2019-02-01
00365649850035Solesta®SALIX PHARMACEUTICALS, LTD.LNM2014-10-31
00365649922039Deflux®SALIX PHARMACEUTICALS, LTD.LNM2014-10-31
08714729804796CoaptiteMERZ NORTH AMERICA, INC.LNM2014-09-17
00858015005004Durasphere ® EXP Carbon Medical Technologies, Inc.LNM2014-09-17
00858015005011Durasphere ® EXPCarbon Medical Technologies, Inc.LNM2014-09-17
08717591240266Macroplastique ImplantsUroplasty, Inc.LNM2014-06-20