GluSeal® GLUSEAL5(C)HV

GUDID D795191

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: D795191
• NIH Device Record Key: 8b46d7d0-7f95-42f0-b34e-a92787073af6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GluSeal®
• Version Model Number: GLUSEAL5(C)HV
• Catalog Number: GLUSEAL5(C)HV
• 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: true
• Device Combination Product: false
• Single Use: false
• 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	D795191 [Primary]

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