FDA.reportPublic FDA data

Medline

Primary DI
20197344009401
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
OTC
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11
10812564036381MedlineSYN3872SYN38722026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344009404MedlineMEDLINE 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