GluSeal®90 GLUSEAL0.5(ST)

GUDID B439033

GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns and minor irritation of the the skin and help protect them from inf

SKINSTITCH CORP.

Skin-approximation adhesive

• Primary Device ID: B439033
• NIH Device Record Key: 11f6fb0c-77f7-4ed3-ad3b-6b8f259c6153
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GluSeal®90
• Version Model Number: GLUSEAL0.5(ST)
• Catalog Number: GLUSEAL0.5(ST)
• 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: false
• 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	B439033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083752

FDA Product Code

• KMF: Bandage, Liquid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-17
• Device Publish Date: 2018-08-16

On-Brand Devices [GluSeal®90]

• B439033: GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns and minor ir
• B439023: GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns and minor ir