Jacket Biopsy Valve

Basic Information

• Brand Name: Jacket Biopsy Valve
• Primary DI: 00858276007243
• Version / Model: MD-A-BV02
• Company Name: Micro-tech Usa
• Labeler DUNS: 079873914
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-03
• Public Version: 1
• Public Version Date: 2025-03-11
• Public Version Status: New
• Public Device Record Key: 0491e1d8-afa0-40f7-9205-fdf773057eee

Device Description

Jacket Disp Biopsy Valve Olym/Fuji

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62145	Endoscope working-channel valve, single-use	A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00858276007250	GS1	Box	100	In Commercial Distribution
Primary	00858276007243	GS1
Package	00858276007786	GS1	Case	5	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K173758	000