GluStitch® Twist

GUDID B439013

GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied

SKINSTITCH CORP.

Skin-approximation adhesive

• Primary Device ID: B439013
• NIH Device Record Key: 54d03870-fa0d-4100-a83d-d06bc664c4c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GluStitch® Twist
• Version Model Number: GLTWI05
• Company DUNS: 825880623
• Company Name: SKINSTITCH CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-254-3900
• Email: sales@skinstitch.com
• Phone: 1-866-254-3900
• Email: sales@skinstitch.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B439013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150032

FDA Product Code

• MPN: Tissue Adhesive For The Topical Approximation Of Skin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-01

Devices Manufactured by SKINSTITCH CORP.

• B439023 - GluSeal®90: 2018-09-17 GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns and minor irritation of the the skin and hel
• B439033 - GluSeal®90: 2018-09-17 GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns and minor irritation of the the skin and hel
• B439013 - GluStitch® Twist: 2018-07-06GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied
• B439013 - GluStitch® Twist: 2018-07-06 GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissu