FDA.reportPublic FDA data

Exofin Fusion Skin Closure System SourceMark, 6cm

Primary DI
10854137001808
Brand
Exofin Fusion Skin Closure System SourceMark, 6cm
Company
CHEMENCE MEDICAL PRODUCTS, INC.
Model
M1266
Catalog number
M1266
Published
2022-05-17
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
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
10854137001808PackageGS16In Commercial Distribution
00854137001801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085413700180810854137001808
00854137001801008541370018018541370018010854137001801

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18446334583customerservice@chemence.com

Regulatory Flags#

DUNS number
079163089
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854137001730GluGone Adhesive Remover, 0.67 oz.GG80148GG801482022-06-27
10854137001754exofin Fusion Skin Closure System SourceMark, 60cmM1244M12442022-05-17
00854137001610Exofin Fusion Skin Closure System, 6cmEF704062022-05-13
00854137001511exofin Fusion Skin Closure System, 60cmEF70466EF704662022-02-14
30854137001147exofin HVTA ST&G, 1g Box of 10EX70407EX704072022-02-14
10854137001655Premier Pro Exofin Precision Pen34752021-12-08
00854137001641eXofin Precision Pen High Viscosity Topical Skin AdhesiveEP704122021-11-10
10854137001679Premier Pro Exofin HVTA 347034702021-11-08
10854137001624eXofin High Viscosity Topical Skin AdhesiveEX704102021-10-29
00854137001481Exofin XLEX720062019-05-30
10854137001235Exofin Fusion Skin Closure System22cmEF704012017-10-25
20854137001195OctylbondM1201M12012016-10-18

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
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
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