GluSeal® GLUSEAL(C)

GUDID D795183

GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.

Glustich Inc

Skin-approximation adhesive

• Primary Device ID: D795183
• NIH Device Record Key: 6472fb3f-9ec4-469c-9c9c-8d19af673aa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GluSeal®
• Version Model Number: GLUSEAL(C)
• Catalog Number: GLUSEAL(C)
• 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: false
• 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	D795180 [Primary]
HIBCC	D795183 [Package]; Contains: D795180; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030574

FDA Product Code

• KMF: Bandage, Liquid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-07

On-Brand Devices [GluSeal®]

• D795210: GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr
• D795201: GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr
• D795191: GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr
• D795183: GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr
• D795173: GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr
• D795161: GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr
• D795151: GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr