Single Use Rotatable Clip Fixing Device

Basic Information

• Brand Name: Single Use Rotatable Clip Fixing Device
• Primary DI: 04953170353154
• Version / Model: HX-201UR-135L
• Catalog Number: N5354230
• 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: 5
• Public Version Date: 2023-08-30
• Public Version Status: Update
• Public Device Record Key: 7f865ab1-5081-4a4e-b42a-09d0bd83d96e

Device Description

Single Use Rotatable Clip Fixing Device

Device Characteristics

• Single Use: Yes
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MND	Ligator, esophageal	Gastroenterology, Urology	876.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35649	Ligation clip, metallic	A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14953170353151	GS1		20	In Commercial Distribution
Primary	04953170353154	GS1
Package	54953170353159	GS1		4	Not in Commercial Distribution	2023-08-29

Customer Contacts

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