Unipack UBC-8047

GUDID 30665973031812

Barrier Film 4" x 6" 1200 sheets/roll Pink

Dukal LLC

Medical equipment/instrument drape, single-use

• Primary Device ID: 30665973031812
• NIH Device Record Key: aba362aa-5cc6-4b49-9d8c-e3725ae464b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unipack
• Version Model Number: UBC-8047
• Catalog Number: UBC-8047
• Company DUNS: 791014871
• Company Name: Dukal LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20665973031815 [Primary]
GS1	30665973031812 [Package]; Contains: 20665973031815; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183263

FDA Product Code

• PEM: Dental barriers and sleeves

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: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [Unipack]

• 30665973031836: Barrier Film 4" x 6" 1200 sheets/roll Clear
• 30665973031829: Barrier Film 4" x 6" 1200 sheets/roll Blue
• 30665973031812: Barrier Film 4" x 6" 1200 sheets/roll Pink