FDA.reportPublic FDA data

BondEase

Primary DI
00850081858102
Brand
BondEase
Company
Optmed Inc
Model
BE100
Device description
Topical Skin Adhesive
Published
2026-03-20
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243990000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243990000BondEase 2 Topical Skin AdhesiveOptmed, Inc.2025-09-19MPN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850081858102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850081858102008500818581028500818581020850081858102

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
026944109
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850081858003NaavaBondNB1002026-01-15
00860013046415TearRepairTR1002025-05-30

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
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
20888277728605MedlineMEDLINE INDUSTRIES, INC.MPN2021-01-11