Aspen® Endoscopic Kittner, Double Tip

GUDID 10887761000015

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

ASPEN SURGICAL PRODUCTS, INC.

Dissection sponge Dissection sponge Dissection sponge Dissection sponge Dissection sponge Dissection sponge Dissection sponge Dissection sponge Dissection sponge Dissection sponge Dissection sponge Dissection sponge Dissection sponge Dissection sponge Dissection sponge

• Primary Device ID: 10887761000015
• NIH Device Record Key: 5e850c11-8995-4ee1-9588-47c41ed262a8
• 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
• 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	00887761000018 [Primary]
GS1	10887761000015 [Package]; Contains: 00887761000018; Package: [20 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-12-18
• Device Publish Date: 2016-09-17

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