Distal Attachment

Basic Information

• Brand Name: Distal Attachment
• Primary DI: 04953170047732
• Version / Model: MH-462
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 6
• Public Version Date: 2022-08-11
• Public Version Status: Update
• Public Device Record Key: 7feb37ba-6c32-469b-b2d3-2130f20993e7
• Distribution End Date: 2022-08-10

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: High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDS	Gastroscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65404	Endoscope tissue removal cap, reusable	A plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue from the path of the endoscope during endoscopic surgery. It is designed to fit tightly without fixing, having an oblique leading edge that extends beyond the end of the endoscope to provide atraumatic penetration and tissue removal functionality (e.g., scooping, grasping). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170047732	GS1
Unit of Use	84953170047738	GS1

Customer Contacts

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