Unipack UPP-3565

GUDID 30665973032512

Sterilization Pouches - 3-1/2" x 6-1/2"

Dukal LLC

Sterilization packaging, single-use

• Primary Device ID: 30665973032512
• NIH Device Record Key: 7fa7c7a5-f5ee-43c4-845e-eb05820af2d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unipack
• Version Model Number: UPP-3565
• Catalog Number: UPP-3565
• Company DUNS: 791014871
• Company Name: Dukal LLC
• Device Count: 200
• 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: true
• 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
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00665973032511 [Unit of Use]
GS1	20665973032515 [Primary]
GS1	30665973032512 [Package]; Contains: 20665973032515; Package: Case [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162258

FDA Product Code

• FRG: Wrap, sterilization

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: 2025-06-09
• Device Publish Date: 2025-06-01

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
• 50665973032578: Sterilization Pouches - 3 1/2" x 10" -1000 bx
• 50665973032561: Sterilization Pouches - 2-3/4" x 10" -1000 bx
• 30665973032574: Sterilization Pouches- 3 1/2" x 10"
• 30665973032567: Sterilization Pouches- 2-3/4" x 10"
• 30665973032550: Sterilization Pouches - 7-1/2" x 13"
• 30665973032543: Sterilization Pouches - 5-1/4" x 7-1/2"
• 30665973032536: Sterilization Pouches - 5-1/4" x 11"
• 30665973032529: Sterilization Pouches - 4-1/4" x 12"
• 30665973032512: Sterilization Pouches - 3-1/2" x 6-1/2"
• 30665973032505: Sterilization Pouches - 3-1/4" x 12"
• 30665973032499: Sterilization Pouches - 2" x 9"
• 30665973032482: Sterilization Pouches - 2-1/4" x 5"
• 30665973032475: Sterilization Pouches - 2-1/4" x 3-3/4"
• 30665973032451: Sterilization Pouches - 10" x 15"