FDA.reportPublic FDA data

Exofin XL

Primary DI
00854137001481
Brand
Exofin XL
Company
CHEMENCE MEDICAL PRODUCTS, INC.
Model
EX72006
Device description
Topical Tissue Adhesive
Published
2019-05-30
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

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
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.

Sterilization Methods#

Method table
Method

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
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
10854137001808Exofin Fusion Skin Closure System SourceMark, 6cmM1266M12662022-05-17
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
10854137001235Exofin Fusion Skin Closure System22cmEF704012017-10-25
20854137001195OctylbondM1201M12012016-10-18

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