ASO EU® Wound Closure

GUDID 20887761000685

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 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 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: 20887761000685
• NIH Device Record Key: f3631807-b807-456f-8ade-7425cfab837a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASO EU® Wound Closure
• Version Model Number: 40-2893
• 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
• 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
• 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	00887761000681 [Primary]
GS1	10887761000688 [Package]; Contains: 00887761000681; Package: [50 Units]; In Commercial Distribution
GS1	20887761000685 [Package]; Contains: 10887761000688; Package: [4 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: true

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

Devices Manufactured by ASPEN SURGICAL PRODUCTS, INC.

• 00840113231485 - Amnihook Amniotic Membrane Perforator: 2023-03-07 Stork AmniHook, Amniotic Membrane Perforator, Yellow, Sterile, 1/pouch, 100pouches/box
• 00840113231508 - Double-Grip Umbilical Cord Clamp: 2023-03-07 Double Grip Umbilical Cord Clamps – Sterile
• 00840113231539 - PlastiBell Circumcision Device: 2023-03-07 PlastiBell Circumcision Device, Hospital Bulk Pack
• 00840113231546 - PlastiBell Circumcision Device: 2023-03-07 1.1 cm PlastiBell Circumcision Device
• 00840113231560 - PlastiBell Circumcision Device: 2023-03-07 1.2 cm PlastiBell Circumcision Device
• 00840113231577 - PlastiBell Circumcision Device: 2023-03-07 1.3 cm PlastiBell Circumcision Device
• 00840113231584 - PlastiBell Circumcision Device: 2023-03-07 1.4 cm PlastiBell Circumcision Device
• 00840113231591 - PlastiBell Circumcision Device: 2023-03-07 1.5 cm PlastiBell Circumcision Device