FDA.reportPublic FDA data

exofin Fusion Skin Closure System SourceMark, 60cm

Primary DI
00854137001757
Brand
exofin Fusion Skin Closure System SourceMark, 60cm
Company
Chemence Medical, Inc.
Model
M1244
Catalog number
M1244
Published
2022-05-17
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
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
K171442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171442000Exofin Fusion Skin Closure SystemChemence Medical, Inc.2017-09-25OMD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854137001754PackageGS12In Commercial Distribution
00854137001757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085413700175410854137001754
00854137001757008541370017578541370017570854137001757

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.

Contacts#

Phone, Email table
PhoneEmail
18446334583customerservice@chemence.com

Regulatory Flags#

DUNS number
079163089
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20854137001140exofin HVTA ST&G, 1g Box of 10EX70407EX704072022-02-14
00854137001474Exofin XLEX720062019-05-30
00854137001672exofin HVTSA Premier Pro, 1g347034702021-11-08
20854137001621exofin HVTSA, 1g- Box of 60EX70410EX704102021-10-29
00854137001146exofin HVTA, 1gEX70410EX704102016-09-24
00854137001153exofin MICRO HVTSA, 0.5gEX71010EX710102016-09-24
00854137001689exofin Mastic, 2 oz. EM80212EM802122022-06-27
00854137001696exofin Mastic, 0.67mlEM80148EM801482022-06-27
00854137001702exofin Mastic, 1 oz. EM81512EM815122022-06-27
00854137001740LiquidSkin, 0.5g503 5000 503 50002022-06-27
00854137001191OctylbondM1201M12012016-10-18
00854137001238Exofin Fusion Skin Closure System22cmEF704012017-10-25
00854137001504exofin Fusion Skin Closure System, 60cmEF70466EF704662022-02-14
00854137001603Exofin Fusion Skin Closure System, 6cmEF704062022-05-13
00854137001627exofin HVTSA, 1gEX70410EX704102021-10-29
00854137001634eXofin Precision Pen, 1gEP70412EP704122021-11-10
00854137001658exofin Precision Pen Premier Pro, 1g347534752021-12-08
00854137001733GluGone Adhesive Remover, 0.67 oz.GG80148GG801482022-06-27
00854137001801Exofin Fusion Skin Closure System SourceMark, 6cmM1266M12662022-05-17
00854137001979exofin SCEXSC5G2024-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344009404MedlineMEDLINE INDUSTRIES, INC.OMD2024-03-05
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
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