FDA.reportPublic FDA data

exofin Mastic, 1 oz.

Primary DI
00854137001702
Brand
exofin Mastic, 1 oz.
Company
Chemence Medical, Inc.
Model
EM81512
Catalog number
EM81512
Device description
Class 1
Published
2022-06-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854137001702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854137001702008541370017028541370017020854137001702

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cover sealantA biodegradable, synthetic (e.g., cyanoacrylate) substance intended to be applied over a superficial wound to set and form a barrier to reduce skin exposure to external contaminants. Sometimes referred to as a liquid bandage, it is intended for use in the home or a clinical setting and may be intended as an alternative to a conventional skin-cover adhesive strip. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18446334583customerservice@chemence.com

Regulatory Flags#

DUNS number
079163089
Device count
1
Premarket exempt
true
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
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
00389152744957Adhesive Sleeve, 10 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00389152745459Adhesive Sleeve, 2 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00197998029844Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-05
00311917088556WalgreensWALGREEN CO.KGX2026-09-30
08859922800036EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800043EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
00850087488877CeeportCEEPORT INC.KGX2026-09-29
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25
06979191883744OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883751OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883768OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883775OKTAPEHTT Technologies, Inc.KGX2026-09-02
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23