GluSeal®90 GLUSEAL(ST)

GUDID D795130

GluSeal®90 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 Skin-approximation adhesive

• Primary Device ID: D795130
• NIH Device Record Key: 0e7d2b83-eef1-427c-b5d4-83036cb88eac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GluSeal®90
• Version Model Number: GLUSEAL(ST)
• Catalog Number: GLUSEAL(ST)
• 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	D795130 [Primary]
HIBCC	D795133 [Package]; Package: BOX [12 Units]; In Commercial Distribution

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: 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®90]

• D795220: GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor i
• D795143: GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor i
• D795130: GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor i