InnoSEAL Hemostatic Pad

GUDID 08800030700121

InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of chitosan and catechol conjugated chitosan which are biocompatible. InnoSEAL Hemostatic Pad is applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation.

InnoTherapy Inc.

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• Primary Device ID: 08800030700121
• NIH Device Record Key: f1789249-04d8-4412-8f71-c9ebad06ecf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InnoSEAL Hemostatic Pad
• Version Model Number: IS-H-01-10
• Company DUNS: 688398443
• Company Name: InnoTherapy 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com
• Phone: 999-999-9999
• Email: changkim@innotherapy.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800030700121 [Primary]
GS1	08800030700145 [Package]; Package: CCP paper box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161013

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-10
• Device Publish Date: 2019-05-07