FDA.reportPublic FDA data

Exofin XL

Primary DI
00854137001474
Brand
Exofin XL
Company
Chemence Medical, Inc.
Model
EX72006
Device description
Topical Tissue Adhesive
Published
2019-05-30
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854137001481PackageGS16In Commercial Distribution
00854137001474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854137001481008541370014818541370014810854137001481
00854137001474008541370014748541370014740854137001474

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.

Regulatory Flags#

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