N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04035873068662
• Version / Model: 8300053516
• Catalog Number: 8300053516
• Company Name: Henke-Sass, Wolf GmbH
• Labeler DUNS: 317326411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-18
• Public Version: 1
• Public Version Date: 2021-02-26
• Public Version Status: New
• Public Device Record Key: b8dbafdf-523f-4a8a-a250-96f28675062c

Device Description

OPTICAL STONE FORCEPS

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: Yes
• 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
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	884.1690	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37141	Rigid endoscopic stone-retrieval forceps, reusable	A rigid manual device intended to be inserted through the working channel of a compatible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a very long instrument with one sliding and one stationary rod, or a sheath, whose distal ends are equipped with thin grasping claws in which the stone is seized and held for extraction. The claws are typically operated by scissors-like ring handles at the proximal end of the instrument. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035873068662	GS1