Jacket Biopsy Valve

GUDID 00858276007359

Jacket Disp Biopsy Valve Pentax Medical

Micro-tech Usa

Endoscope working-channel valve, single-use

• Primary Device ID: 00858276007359
• NIH Device Record Key: a167daeb-20ae-46b5-ae2d-5f7e65c2ec08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jacket Biopsy Valve
• Version Model Number: MD-B-BV02
• Company DUNS: 079873914
• Company Name: Micro-tech Usa
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858276007335 [Primary]
GS1	00858276007359 [Package]; Contains: 00858276007335; Package: Box [100 Units]; In Commercial Distribution
GS1	00858276007779 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173758

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-11
• Device Publish Date: 2025-03-03

On-Brand Devices [Jacket Biopsy Valve]

• 00858276007359: Jacket Disp Biopsy Valve Pentax Medical
• 00858276007250: Jacket Disp Biopsy Valve Olym/Fuji