Disposable Biopsy Valve

GUDID 10850025860762

Disp Biopsy Valve Pentax Sterile

Micro-tech Usa

Endoscope working-channel valve, single-use

• Primary Device ID: 10850025860762
• NIH Device Record Key: 2743f057-eecf-47c8-b532-557dc8d258e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Biopsy Valve
• Version Model Number: BW01-PENB
• 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	00850025860765 [Primary]
GS1	10850025860762 [Package]; Contains: 00850025860765; Package: Box [100 Units]; In Commercial Distribution
GS1	20850025860769 [Package]; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220210

FDA Product Code

• ODC: Endoscope Channel Accessory

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-12
• Device Publish Date: 2025-03-04

On-Brand Devices [Disposable Biopsy Valve]

• 10850025860762: Disp Biopsy Valve Pentax Sterile
• 10850025860748: Disp Biopsy Valve Olym/Fuji Sterile