ZipSeal 16 Surgical Skin Closure Kit PS1163

GUDID 00853114007225

ZipSeal 16 Surgical Skin Closure Kit Convenience Kit Contains: Five (5) ZipLine Medical Zip® 16 Surgical Skin Closure Devices DI=00865379000019 FDA Product Code=KGX GMDN=34864 Class I, 510(k) Exempt Five (5) Cardinal HealthTM Topical Skin Adhesive DI=10885380101588 FDA Product Code=MPN GMDN=34164 Class II, Submission #K132243

ZIPLINE MEDICAL, INC.

Skin-approximation adhesive

• Primary Device ID: 00853114007225
• NIH Device Record Key: 77056ec2-e489-41da-b56d-c95ecf832473
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZipSeal 16 Surgical Skin Closure Kit
• Version Model Number: PS1163
• Catalog Number: PS1163
• Company DUNS: 962534124
• Company Name: ZIPLINE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: 888-326-8999
• Email: customerservice@ziplinemedical.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com
• Phone: +1(800)253-3210
• Email: INS.Stryker.CS@stryker.com

Device Dimensions

• Length: 16 Centimeter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 16 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853114007225 [Primary]

FDA Product Code

• MCY: Wound Dressing Kit

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: 2019-03-04
• Device Publish Date: 2019-01-30

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