FDA.reportPublic FDA data

GluSeal®

Primary DI
D795210
Brand
GluSeal®
Company
Glustich Inc
Model
GLUSEAL(C)HV
Catalog number
GLUSEAL(C)HV
Device description
GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.
Published
2018-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMFBandage, Liquid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMFBandage, LiquidGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030574000GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSERGlustitch, Inc.2003-08-21KMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D795213PackageHIBCC12In Commercial Distribution
D795210PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
1-877-940-2262info@glustitch.com

Regulatory Flags#

DUNS number
201637158
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D795201GluSeal®GLUSEALPTGLUSEALPT2017-07-28
D795231PeriAcryl®P-ACRYL2(V)HVP-ACRYL2(V)HV2022-01-06
D7950000010PeriAcrylP-ACRYLU(V)2017-02-13
D7950000030PeriAcrylP-ACRYLU(C)2017-02-13
D7950000130GLUSTITCH TWISTGLTWI052017-02-13
D795G000150GLUSTITCH TWISTGLTWI05C2017-02-13
D7950000021PeriAcrylP-ACRYLU(V)2017-02-13
D7950000041PeriAcrylP-ACRYLU(C)2017-02-13
D7950000050PeriAcrylP-ACRYLU(V)HV2017-02-13
D7950000131GLUSTITCH TWISTGLTWI052017-02-13
D795G000151GLUSTITCH TWISTGLTWI05C2017-02-13
D795220GluSeal®90GLUSEAL0.5(ST)GLUSEAL0.5(ST)2018-08-16
D795010PeriAcryl®P-ACRYLU(V)P-ACRYLU(V)2017-02-06
D795020PeriAcryl®P-ACRYLU(C)P-ACRYLU(C)2017-02-07
D795030PeriAcryl®P-ACRYLU(V)HVP-ACRYLU(V)HV2017-02-07
D795110GluStitch® TwistGLTWI05GLTWI052017-02-07
D795120GluStitch® TwistGLTWI05CGLTWI05C2017-02-07
D795140GluSeal®90GLUSEAL(ST)CGLUSEAL(ST)C2017-04-07
D795170GluSeal®GLUSEAL(V)GLUSEAL(V)2017-04-07
D795180GluSeal®GLUSEAL(C)GLUSEAL(C)2017-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253047967KendallCardinal Health 200, LLCKMF2026-05-26
10192253047974KendallCardinal Health 200, LLCKMF2026-05-13
10192253047943KendallCardinal Health 200, LLCKMF2026-05-12
10192253047950KendallCardinal Health 200, LLCKMF2026-05-12
007073878171523M™ Cavilon™3M COMPANYKMF2026-04-17
00858071004034Natural Seal Wound Dressing 1ozKericure Inc.KMF2025-10-03
00858071004256Advanced Seal Wound Barrier, 1oz sprayKericure Inc.KMF2025-08-21
00860013046415TearRepairOptmed IncKMF2025-05-30
10888277719743MedlineMEDLINE INDUSTRIES, INC.KMF2024-03-05
20888277719740MedlineMEDLINE INDUSTRIES, INC.KMF2024-03-05
10192253048087KendallCardinal Health 200, LLCKMF2024-03-04
10192253048094KendallCardinal Health 200, LLCKMF2024-03-04
10192253048100KendallCardinal Health 200, LLCKMF2024-03-04
10192253048117KendallCardinal Health 200, LLCKMF2024-03-04
20192253048084KendallCardinal Health 200, LLCKMF2024-03-04
20192253048091KendallCardinal Health 200, LLCKMF2024-03-04
20192253048107KendallCardinal Health 200, LLCKMF2024-03-04
20192253048114KendallCardinal Health 200, LLCKMF2024-03-04
10192253046908CurityCardinal Health 200, LLCKMF2023-11-03
20192253046905CurityCardinal Health 200, LLCKMF2023-11-03
10192253046861CurityCardinal Health 200, LLCKMF2023-10-25
10192253046885CurityCardinal Health 200, LLCKMF2023-10-25
20192253046875CurityCardinal Health 200, LLCKMF2023-10-25
20192253046868CurityCardinal Health 200, LLCKMF2023-10-25
20192253046882CurityCardinal Health 200, LLCKMF2023-10-25
30192253046872CurityCardinal Health 200, LLCKMF2023-10-25
10192253046847CurityCardinal Health 200, LLCKMF2023-10-24
10192253046854CurityCardinal Health 200, LLCKMF2023-10-24
20192253046844CurityCardinal Health 200, LLCKMF2023-10-24
20192253046851CurityCardinal Health 200, LLCKMF2023-10-24