FDA.reportPublic FDA data

exofin Mastic, 0.67ml

Primary DI
00854137001696
Brand
exofin Mastic, 0.67ml
Company
Chemence Medical, Inc.
Model
EM80148
Catalog number
EM80148
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
10854137001693PackageGS14In Commercial Distribution
20854137001690PackageGS112In Commercial Distribution
00854137001696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085413700169310854137001693
2085413700169020854137001690
00854137001696008541370016968541370016960854137001696

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
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
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102747MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20