FDA.reportPublic FDA data

GluStitch® Twist

Primary DI
B439013
Brand
GluStitch® Twist
Company
SKINSTITCH CORP.
Model
GLTWI05
Device description
GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive. GluStitch Twist Tissue Adhesive is intended for the topical closure of surgical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch Twist may be used in conjunction with, but not in place of, deep dermal stitches.
Published
2017-05-01
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

Contact Domains#

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
K150032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150032000GluStitch Twist Tissue AdhesiveGlustitch, Inc.2016-01-14MPN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B439013PrimaryHIBCC0

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
1-866-254-3900sales@skinstitch.com

Regulatory Flags#

DUNS number
825880623
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B439023GluSeal®90GLUSEAL(ST)GLUSEAL(ST)2018-08-16
B439033GluSeal®90GLUSEAL0.5(ST)GLUSEAL0.5(ST)2018-08-16

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00854137001627exofin HVTSA, 1gChemence Medical, Inc.MPN2021-10-29
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