HOT BIOPSY FORCEPS

Basic Information

• Brand Name: HOT BIOPSY FORCEPS
• Primary DI: 04953170049118
• Version / Model: FD-7C-1
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 8
• Public Version Date: 2023-10-30
• Public Version Status: Update
• Public Device Record Key: 253f3532-518d-4bf6-96ca-9ed544e2c396
• Distribution End Date: 2022-08-15

Device Description

FD-7C-1.B HOT BIOPSY FORCEPS 2.0MM

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FGA	Kit, nephroscope	Gastroenterology, Urology	876.1500	2
KGE	FORCEPS, BIOPSY, ELECTRIC	Gastroenterology, Urology	876.4300	2
FAJ	Cystoscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33596	Endoscopic electrosurgical handpiece/electrode, monopolar, reusable	An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14953170049115	GS1		1	Not in Commercial Distribution	2022-08-15
Primary	04953170049118	GS1

Customer Contacts

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