Aspen® Skin Closure

GUDID 10887761000541

Intended for skin closure and closure support for sutures and staples

ASPEN SURGICAL PRODUCTS, INC.

Skin-closure adhesive strip

• Primary Device ID: 10887761000541
• NIH Device Record Key: bfe62c42-4ded-4bb7-91ac-5e3275ffe8f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspen® Skin Closure
• Version Model Number: 1046NS
• Company DUNS: 027680821
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Device Count: 5000
• 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: true
• 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: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887761000544 [Unit of Use]
GS1	10887761000541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874813

FDA Product Code

• FPX: Strip, adhesive, closure, skin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-18
• Device Publish Date: 2018-12-13

On-Brand Devices [Aspen® Skin Closure]

• 10887761000541: Intended for skin closure and closure support for sutures and staples
• 10887761000534: Intended for skin closure and closure support for sutures and staples
• 00887761000568: Intended for skin closure and closure support for sutures and staples
• 00887761000551: Intended for skin closure and closure support for sutures and staples
• 00840113201389: Intended for skin closure and closure support for sutures and staples
• 00840113201372: Intended for skin closure and closure support for sutures and staples
• 00840113201358: Intended for skin closure and closure support for sutures and staples
• 00840113201327: Intended for skin closure and closure support for sutures and staples