SINGLE USE BIOPSY VALVE (Sterile)

Basic Information

• Brand Name: SINGLE USE BIOPSY VALVE (Sterile)
• Primary DI: 14953170154291
• Version / Model: MAJ-1218
• Catalog Number: N1058800
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 8
• Public Version Date: 2023-12-28
• Public Version Status: Update
• Public Device Record Key: 3bb6c192-93ea-4f56-8b8f-7d6f979e8176

Device Description

SINGLE USE BIOPSY VALVE MAJ-1218

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: No
• 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
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	874.4760	2
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	874.4680	2
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62145	Endoscopic biopsy valve, single-use	A device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14953170154291	GS1
Unit of Use	04953170154294	GS1
Package	54953170154299	GS1		70	Not in Commercial Distribution	2023-09-19

Customer Contacts

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