Aspen® Endoscopic Kittner, Double Tip

GUDID 00840113213993

This product is single use and intended to be used for blunt dissection of tissue

ASPEN SURGICAL PRODUCTS, INC.

Dissection sponge

• Primary Device ID: 00840113213993
• NIH Device Record Key: 26f5fd41-ca90-4b26-b7a0-f0a9af8b8117
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspen® Endoscopic Kittner, Double Tip
• Version Model Number: KT-9105
• 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: true
• 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	00840113213993 [Package]; Contains: 00840113214013; Package: [20 Units]; In Commercial Distribution
GS1	00840113214013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913500

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

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: 2021-03-05
• Device Publish Date: 2021-02-25

On-Brand Devices [Aspen® Endoscopic Kittner, Double Tip]

• 10887761000015: This product is single use and intended to be used for blunt dissection of tissue
• 00840113213993: This product is single use and intended to be used for blunt dissection of tissue