FDA.reportPublic FDA data

Deflux

Primary DI
00850004725009
Brand
Deflux
Company
PALETTE LIFE SCIENCES, INC.
Model
Gel 1.0 mL Syringe
Catalog number
011504
Device description
Deflux injectable gel
Published
2019-02-01
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
LNMAgent, Bulking, Injectable For Gastro-Urology Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00850004725009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004725009008500047250098500047250090850004725009

GMDN Terms#

Term, Definition table
TermDefinition
Urinary tract reconstructive material, microbe-derivedA sterile, bioabsorbable material intended for submucosal injection in the urinary tract (urethra, urinary bladder, and/or distal ureter) to add volume by serving as a space-occupying supplement (bulking agent) to the intercellular matrix of connective tissue in the treatment of stress urinary incontinence (SUI) and/or vesicoureteral reflux (VUR); it does not include a local anaesthetic agent. It is in the form of a gel of biosynthesized dextranomer microspheres and hyaluronic acid (HA) derived from bacteria. The material is typically preloaded in a disposable syringe.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00Protect from freezing and sunlight
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

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
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
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
00850004725023Deflux Metal NeedlePALETTE LIFE SCIENCES, INC.LNM2019-02-11
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