Tissue Seal TS1050071-FP

GUDID 10860000589021

Topical Skin Adhesive Clear

TISSUE SEAL L.L.C.

Skin-approximation adhesive

• Primary Device ID: 10860000589021
• NIH Device Record Key: 90b20fcf-2ad5-4346-bbb1-3e7d6c4c877c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue Seal
• Version Model Number: TS1050071-FP
• Catalog Number: TS1050071-FP
• Company DUNS: 805666588
• Company Name: TISSUE SEAL L.L.C.
• 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: 877-754-6458
• Email: info@tissueseal.com

Device Dimensions

• Total Volume: 0.5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000589024 [Primary]
GS1	10860000589021 [Package]; Contains: 00860000589024; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111959

FDA Product Code

• MPN: Tissue Adhesive For The Topical Approximation Of Skin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-09
• Device Publish Date: 2019-12-01

On-Brand Devices [Tissue Seal]

• 10860000589038: Topical Skin Adhesive Flex with Tips
• 10860000589021: Topical Skin Adhesive Clear
• 00860000589000: Topical Skin Adhesive Blue