Aspen® Endoscopic Kittner, Single Tip

Basic Information

• Brand Name: Aspen® Endoscopic Kittner, Single Tip
• Primary DI: 00887761000001
• Version / Model: KT-9101
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Labeler DUNS: 027680821
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 8
• Public Version Date: 2024-01-05
• Public Version Status: Update
• Public Device Record Key: 99737068-0726-43eb-9dc1-d8c417f388ef
• Distribution End Date: 2023-08-01

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13698	Dissection sponge	A sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10887761000008	GS1		20	Not in Commercial Distribution	2023-08-01
Primary	00887761000001	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]