ZipSeal 24 Surgical Skin Closure Kit PS1243

GUDID 00853114007232

ZipSeal 24 Surgical Skin Closure Kit Convenience Kit Contains: Three (3) ZipLine Medical Zip® 24 Surgical Skin Closure Devices DI=00865319000057 FDA Product Code=KGX GMDN=34864 Class I, 510(k) Exempt Three (3) Cardinal HealthTM Topical Skin Adhesive DI=10885380101588 FDA Product Code=MPN GMDN=34164 Class II, Submission #K132243

ZIPLINE MEDICAL, INC.

Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage Adhesive bandage

• Primary Device ID: 00853114007232
• NIH Device Record Key: a51db286-5f78-4b69-aacd-fe95cfb80398
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZipSeal 24 Surgical Skin Closure Kit
• Version Model Number: PS1243
• Catalog Number: PS1243
• 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
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com

Device Dimensions

• Length: 24 Centimeter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 Centimeter
• Total Volume: 0.8 Milliliter
• Length: 24 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
• 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	00853114007232 [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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