FDA.reportPublic FDA data

exofin MICRO HVTSA, 0.5g

Primary DI
00854137001153
Brand
exofin MICRO HVTSA, 0.5g
Company
Chemence Medical, Inc.
Model
EX71010
Catalog number
EX71010
Device description
Micro HVTSA, 0.5g and HVTSA SourceMark Product code M1206 and M1206-01
Published
2016-09-24
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
MPNTissue Adhesive For The Topical Approximation Of Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPNTissue Adhesive For The Topical Approximation Of SkinGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152476000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152476000Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc.2016-02-09MPN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854137001252PackageGS110In Commercial Distribution
10854137001150PackageGS16In Commercial Distribution
10854137001259PackageGS160In Commercial Distribution
20854137001157PackageGS16In Commercial Distribution
30854137001154PackageGS110In Commercial Distribution
40854137001151PackageGS16In Commercial Distribution
00854137001153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854137001252008541370012528541370012520854137001252
1085413700115010854137001150
1085413700125910854137001259
2085413700115720854137001157
3085413700115430854137001154
4085413700115140854137001151
00854137001153008541370011538541370011530854137001153

GMDN Terms#

Term, Definition table
TermDefinition
Skin-approximation adhesiveA sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-633-6583customerservice@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
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
00854137001757exofin Fusion Skin Closure System SourceMark, 60cmM1244M12442022-05-17
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
08904255228665MERIGLUETM – Topical Skin AdhesiveMERIL ENDO SURGERY PRIVATE LIMITEDMPN2026-04-18
08904255228672MERIGLUETM – Topical Skin AdhesiveMERIL ENDO SURGERY PRIVATE LIMITEDMPN2026-04-18
08904255228689MERIGLUETM – Topical Skin AdhesiveMERIL ENDO SURGERY PRIVATE LIMITEDMPN2026-04-18
00850081858102BondEaseOptmed IncMPN2026-03-20
00850081858003NaavaBondOptmed IncMPN2026-01-15
00854137001979exofin SCChemence Medical, Inc.MPN2024-06-20
10304040178857Henry ScheinHENRY SCHEIN, INC.MPN2024-01-12
00304040178850Henry ScheinHENRY SCHEIN, INC.MPN2024-01-12
05036912000758LiquiBand ButylADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001687LiquiBand ExceedADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001717LiquiBand Exceed XSADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001748LiquiBand Octyl MiniADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912000406LiquiBand ButylADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001694LiquiBand ExceedADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001724LiquiBand Exceed XSADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001755LiquiBand Octyl MiniADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
20854137001140exofin HVTA ST&G, 1g Box of 10Chemence Medical, Inc.MPN2022-02-14
30854137001147exofin HVTA ST&G, 1g Box of 10CHEMENCE MEDICAL PRODUCTS, INC.MPN2022-02-14
00811220033521PremierProPRESTIGE AMERITECH, LTD.MPN2022-01-14
00811220033538PremierProSVS LLCMPN2022-01-14
00854137001658exofin Precision Pen Premier Pro, 1gChemence Medical, Inc.MPN2021-12-08
10854137001655Premier Pro Exofin Precision PenCHEMENCE MEDICAL PRODUCTS, INC.MPN2021-12-08
00854137001634eXofin Precision Pen, 1gChemence Medical, Inc.MPN2021-11-10
00854137001641eXofin Precision Pen High Viscosity Topical Skin AdhesiveCHEMENCE MEDICAL PRODUCTS, INC.MPN2021-11-10
00854137001672exofin HVTSA Premier Pro, 1gChemence Medical, Inc.MPN2021-11-08
10854137001679Premier Pro Exofin HVTA CHEMENCE MEDICAL PRODUCTS, INC.MPN2021-11-08
00854137001627exofin HVTSA, 1gChemence Medical, Inc.MPN2021-10-29
10854137001624eXofin High Viscosity Topical Skin AdhesiveCHEMENCE MEDICAL PRODUCTS, INC.MPN2021-10-29
20854137001621exofin HVTSA, 1g- Box of 60Chemence Medical, Inc.MPN2021-10-29
10888277728608MedlineMEDLINE INDUSTRIES, INC.MPN2021-01-11