FDA.reportPublic FDA data

Medline

Primary DI
10197344009404
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MSC091080
Catalog number
MSC091080
Device description
LIQUIBAND SECURE WOUND CLOSURE, 66CM
Published
2024-03-05
Public version status
New
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
OMDCutaneous tissue adhesive with mesh

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMDCutaneous Tissue Adhesive With MeshGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211878000LiquiBand XLAdvanced Medical Solutions Limited2022-05-23OMD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344009401PackageGS12In Commercial Distribution
30197344009408PackageGS112In Commercial Distribution
10197344009404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734400940120197344009401
3019734400940830197344009408
1019734400940410197344009404

GMDN Terms#

Term, Definition table
TermDefinition
Wound closure set, topicalA collection of sterile devices used to topically close easily-approximated skin edges of wounds. It typically includes a pressure-sensitive adhesive tape or mesh and a liquid adhesive, each contained within a dispensing applicator. The tape/mesh is first applied to temporarily approximate the skin edges followed by application of the liquid adhesive, over the tape/mesh, which polymerizes to affect wound closure. This set may be used to treat surgical incisions, simple lacerations, and may also be used in conjunction with deep dermal stitches. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Shield from direct sunlight.
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489086331MEDLINEMDS9082111MDS90821112026-08-27
10197344011858HUDSON RCIHUD1695HUD16952026-08-27
10197344011865HUDSON RCIHUD1694HUD16942026-08-27
10197344011872HUDSON RCIHUD1693HUD16932026-08-27
10197344011889HUDSON RCIHUD1692HUD16922026-08-27
10197344011896HUDSON RCIHUD1691HUD16912026-08-27
10197344011902HUDSON RCIHUD1690HUD16902026-08-27
10197344011919HUDSON RCIHUD1689HUD16892026-08-27
10197344011926HUDSON RCIHUD1688HUD16882026-08-27
10197344011933HUDSON RCIHUD1687HUD16872026-08-27
10197344011940HUDSON RCIHUD1686HUD16862026-08-27
10197344011957HUDSON RCIHUD1685HUD16852026-08-27
10197344011964HUDSON RCIHUD1683HUD16832026-08-27
10197344016884HUDSON RCIHUD2701LHUD2701L2026-08-27
10197344016891HUDSON RCIHUD2701MHUD2701M2026-08-27
10197344016938HUDSON RCIHUD2701SHUD2701S2026-08-27
10197344016945HUDSON RCIHUD2701XLHUD2701XL2026-08-27
10197344016969HUDSON RCIHUD2702HUD27022026-08-27
10197344016976HUDSON RCIHUD2703HUD27032026-08-27
10197344016983HUDSON RCIHUD2704HUD27042026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344009401MedlineMEDLINE INDUSTRIES, INC.OMD2024-03-05
20612479267910McKessonMCKESSON MEDICAL-SURGICAL INC.OMD2023-11-13
40612479267921McKessonMCKESSON MEDICAL-SURGICAL INC.OMD2023-11-13
05036912001502LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001533LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001557LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001519LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001540LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001571LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001656LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-03-29
05036912001663LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-03-29
05036912001250LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
05036912001380LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
05036912001472LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
05036912001243LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
05036912001397LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
05036912001489LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
00854137001757exofin Fusion Skin Closure System SourceMark, 60cmChemence Medical, Inc.OMD2022-05-17
00854137001801Exofin Fusion Skin Closure System SourceMark, 6cmChemence Medical, Inc.OMD2022-05-17
10854137001754exofin Fusion Skin Closure System SourceMark, 60cmCHEMENCE MEDICAL PRODUCTS, INC.OMD2022-05-17
10854137001808Exofin Fusion Skin Closure System SourceMark, 6cmCHEMENCE MEDICAL PRODUCTS, INC.OMD2022-05-17
00854137001603Exofin Fusion Skin Closure System, 6cmChemence Medical, Inc.OMD2022-05-13
00854137001610Exofin Fusion Skin Closure System, 6cmCHEMENCE MEDICAL PRODUCTS, INC.OMD2022-05-13
00854137001504exofin Fusion Skin Closure System, 60cmChemence Medical, Inc.OMD2022-02-14
00854137001498exofin Fusion Skin Closure System, 30cmChemence Medical, Inc.OMD2022-02-14
00854137001511exofin Fusion Skin Closure System, 60cmCHEMENCE MEDICAL PRODUCTS, INC.OMD2022-02-14
00811220032876PremierProPRESTIGE AMERITECH, LTD.OMD2020-04-29
10811220032873PremierProSVS LLCOMD2020-04-29
00854137001238Exofin Fusion Skin Closure SystemChemence Medical, Inc.OMD2017-10-25
10854137001235Exofin Fusion Skin Closure SystemCHEMENCE MEDICAL PRODUCTS, INC.OMD2017-10-25