n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551160091
• Version / Model: 40400A
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 60e01b19-2392-459e-8df3-78ebfa1a63d2

Device Description

Forceps, atraumatic, 22 cm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
11787	Lung forceps	A hand-held manual surgical instrument designed to atraumatically grasp, manipulate, or support the lung during a surgical intervention. It typically has a scissors-like, self-retaining, design with ring handles and is made of high-grade stainless steel. It is available in various sizes and the working end will have grasping blades that are shaped as oval rings or triangular-shaped loops that may be serrated to provide better grip on the lung tissue. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551160091	GS1

Premarket Submissions

Submission Number	Supplement Number
K940427	000