Aspen® Skin Closure

GUDID 00840113201389

Intended for skin closure and closure support for sutures and staples

ASPEN SURGICAL PRODUCTS, INC.

Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip

• Primary Device ID: 00840113201389
• NIH Device Record Key: bd4fde67-d935-4d6d-b9e7-dd0891caba84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspen® Skin Closure
• Version Model Number: 1048NS
• Company DUNS: 027680821
• Company Name: ASPEN SURGICAL PRODUCTS, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840113201389 [Primary]
GS1	10840113201386 [Package]; Package: [5000 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-05
• Device Publish Date: 2021-02-25

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