FDA.reportPublic FDA data

TridentX

Primary DI
00370858000164
Brand
TridentX
Company
NEXT SCIENCE, LLC
Model
MC-WW-0005-320
Published
2022-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203446000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203446000TorrentX Wound WashNext Science, LLC2021-09-23FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00370858000164PrimaryGS10
00370858000157Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00370858000164003708580001643708580001640370858000164
00370858000157003708580001573708580001570370858000157

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solution, non-sterileA non-sterile solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridment and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043989331
Device count
320
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10370858000147XPERIENCEMC-SL-0005-102021-04-28
20370858000144XPERIENCEMC-SL-0005-42021-04-28
00370858000225XPERIENCEMC-SL-0005-10D2021-04-28
00370858000232XPERIENCEMC-SL-0005-4D2021-04-28
00370858000355BlastXWG-00032025-04-14
00370858000010BIOWASH Surgical IrrigationBW05002024-07-31
00370858000058BIOWASH Surgical IrrigationBW0500-42024-07-31
00370858000218XPERIENCEMC-SL-0005-1D2021-04-28
00864076000292Bactisure™00-8887-002-002020-12-17
00864076000216BlastX™WG-00012018-07-24
00864076000285BlastX™MC-WG-0003-122018-08-15
00370858000041SurgX™MC-WG-0010-82018-09-20
00370858000072BlastX™MC-WG-0011-302018-09-25
00370858000089BlastX™MC-WG-0003-402018-09-25
00370858000096BlastX™MC-WG-0003-802018-09-25
00370858000270SITEGUARDMC-SL-0008-102022-03-01
00370858000140XPERIENCEMC-SL-0005-42021-04-28
00864076000209Bactisure™00-8887-001-002018-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
05000223503697ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998002861Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432415Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29