Unipack See-Through Self Seal Sterilization Pouch UPP-3565

GUDID D784UPP35651

3-1/2″ X 6-1/2″ - See-Through Self Seal Sterilization Pouch

UNIPACK MEDICAL CORPORATION

Sterilization packaging, single-use

• Primary Device ID: D784UPP35651
• NIH Device Record Key: e9939059-2885-49fb-8372-494a2f003b02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unipack See-Through Self Seal Sterilization Pouch
• Version Model Number: UPP-3565
• Catalog Number: UPP-3565
• Company DUNS: 018319397
• Company Name: UNIPACK MEDICAL CORPORATION
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-686-4722
• Email: 4info@unipackmedical.com
• Phone: 866-686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.com
• Phone: +1(866)686-4722
• Email: 4info@unipackmedical.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
HIBCC	D784UPP35650 [Unit of Use]
HIBCC	D784UPP35651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993764

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

[D784UPP35651]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-15

On-Brand Devices [Unipack See-Through Self Seal Sterilization Pouch]

• D784UPP75131: 7-1/2″ X 13″ - See-Through Self Seal Sterilization Pouch
• D784UPP52751: 5-1/4″ X 7-1/2″ - See-Through Self Seal Sterilization Pouch
• D784UPP52111: 5-1/4″ X 11″ - See-Through Self Seal Sterilization Pouch
• D784UPP42121: 4-1/4″ X 12″ - See-Through Self Seal Sterilization Pouch
• D784UPP35651: 3-1/2″ X 6-1/2″ - See-Through Self Seal Sterilization Pouch
• D784UPP35101K1: 3-1/2″ X 10″ - See-Through Self Seal Sterilization Pouch
• D784UPP35101: 3-1/2″ X 10″ - See-Through Self Seal Sterilization Pouch
• D784UPP32121: 3-1/4″ X 12″ - See-Through Self Seal Sterilization Pouch
• D784UPP291: 2″ x 9″ - See-Through Self Seal Sterilization Pouch
• D784UPP27101K1: 2-3/4″ X 10″ - See-Through Self Seal Sterilization Pouch
• D784UPP27101: 2-3/4″ X 10″ - See-Through Self Seal Sterilization Pouch
• D784UPP2251: 2-1/4″ x 5″ - See-Through Self Seal Sterilization Pouch
• D784UPP12181: 12″ X 18″ - See-Through Self Seal Sterilization Pouch
• D784UPP10151: 10″ X 15″ - See-Through Self Seal Sterilization Pouch