ElaSkin

GUDID 00860001423709

ALEO BME, INC.

Skin-cover sealant

• Primary Device ID: 00860001423709
• NIH Device Record Key: 2588990c-8998-4deb-91c6-b3d7251c3883
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ElaSkin
• Version Model Number: SLB180112
• Company DUNS: 079856690
• Company Name: ALEO BME, 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001423709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171148

FDA Product Code

• KMF: Bandage, Liquid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-05
• Device Publish Date: 2020-01-28