Rotatable Clip Fixing Device

Basic Information

• Brand Name: Rotatable Clip Fixing Device
• Primary DI: 04953170200205
• Version / Model: HX-110QR
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 6
• Public Version Date: 2021-12-06
• Public Version Status: Update
• Public Device Record Key: e01f4543-00b8-4dfc-8cef-6ef57028497c

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
MND	Ligator, esophageal	Gastroenterology, Urology	876.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61206	Gastrointestinal endoscopic clip applier	A device intended to be used in combination with a compatible flexible endoscope for the application of a gastrointestinal endoscopic clip(s) [not included] to the mucosal lining of the gastrointestinal (GI) tract for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects during an endoscopic procedure. It typically consists of an insertion sheath, a mechanism at the distal end for applying the clips, and a control handle at the proximal end for firing the clips into the target tissue. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14953170200202	GS1		1	In Commercial Distribution
Primary	04953170200205	GS1

Customer Contacts

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