GluStitch® Twist GLTWI05C

GUDID D795122

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.

Glustich Inc

Skin-approximation adhesive

• Primary Device ID: D795122
• NIH Device Record Key: af7a7763-a0c7-446e-b1ab-9a49f043796c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GluStitch® Twist
• Version Model Number: GLTWI05C
• Catalog Number: GLTWI05C
• Company DUNS: 201637158
• Company Name: Glustich Inc
• 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: 1-877-940-2262
• Email: info@glustitch.com
• Phone: 1-877-940-2262
• Email: info@glustitch.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D795120 [Primary]
HIBCC	D795121 [Package]; Contains: D795120; Package: BOX [6 Units]; In Commercial Distribution
HIBCC	D795122 [Package]; Contains: D795120; Package: BOX [12 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-07

On-Brand Devices [GluStitch® Twist]

• D795122: GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyano
• D795112: GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyano