FDA.reportPublic FDA data

Avance® Solo

Primary DI
07333350269326
Brand
Avance® Solo
Company
Mölnlycke Health Care AB
Model
8881030
Device description
Avance Solo Set with Dressing 10x30cm
Published
2023-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMPnegative pressure wound therapy Powered suction pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203369000Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC2021-07-01OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333350269326PackageGS12In Commercial Distribution
07333350078478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333350269326073333502693267333350269326
07333350078478073333500784787333350078478

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system, electric, single-useA portable assembly of devices designed to apply suction to help heal traumatic and chronic skin wounds (e.g., grafts, incisions, burns, ulcers) with low to moderate levels of exudate. It typically consists of an electrically-powered vacuum pump, a highly-absorbent wound dressing and/or collection canister to contain the exudate, and a connection tube. The pump applies continuous or intermittent negative pressure to the wound via the tube/dressing to decompress capillaries/lymphatic vessels, improve blood/interstitial fluid circulation, draw wound edges together, facilitate granulation tissue formation, and prepare the wound bed for closure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46737733775pedro.lopes@molnlycke.com

Regulatory Flags#

DUNS number
631770658
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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07333350436575Mepore® Pro6811402026-05-06
07333350477103Mepore® Pro6713202026-05-06
07333350627041Mepore® Pro6712202026-05-06
07333350862176Mepore® Pro6709202026-05-06
07333350872489Mepore®6715002026-05-06
07333350904104Mestopore®6650002026-05-06
07333350917159Mepore® Pro6710202026-05-06
07333350976712Tubigrip®14362026-05-06
07333350996147Mepore®6709702026-05-06
05060097937790Biogel® PI408552022-10-21
05060097937806Biogel® PI408602022-10-21
05060097937813Biogel® PI408652022-10-21
05060097937820Biogel® PI408702022-10-21
05060097937837Biogel® PI408752022-10-21
05060097937844Biogel® PI408802022-10-21
05060097937851Biogel® PI408852022-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719873697724NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697731NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697748NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697755NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697762NACARILEX MEDICAL, INC.OMP2026-08-26
00197998301209Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301285Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301360Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00850084501005Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501029Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501036Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501043Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501050Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501067Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00197998301148Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998301162Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998303906Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998276507Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998300912Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998300936Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313660Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313691Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313752Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313783Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313844Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313905Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00840117350984Durma+ Flexible Suction Bell, With TubingDynarex CorporationOMP2026-06-22
00197998382819Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22