FDA.reportPublic FDA data

GluSeal®

Primary DI
D795173
Brand
GluSeal®
Company
Glustich Inc
Model
GLUSEAL(V)
Catalog number
GLUSEAL(V)
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
2017-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
D795173PackageHIBCC12In Commercial Distribution
D795170PrimaryHIBCC0

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
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
false
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
D795210GluSeal®GLUSEAL(C)HVGLUSEAL(C)HV2018-07-25
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

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