SINGLE USE BIOPSY VALVE (Sterile)

GUDID 14953170247573

Disposable biopsy valve MAJ-1555

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic procedure air/water valve, single-use

• Primary Device ID: 14953170247573
• NIH Device Record Key: ceaa3256-b6ba-461d-ac5a-f206345d5b19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINGLE USE BIOPSY VALVE (Sterile)
• Version Model Number: MAJ-1555
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 20
• DM Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170247576 [Unit of Use]
GS1	14953170247573 [Primary]
GS1	54953170247571 [Package]; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051645

FDA Product Code

• FDF: Colonoscope And Accessories, Flexible/Rigid
• NWB: Endoscope, accessories, narrow band spectrum
• ODC: Endoscope Channel Accessory

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [SINGLE USE BIOPSY VALVE (Sterile)]

• 14953170247573: Disposable biopsy valve MAJ-1555
• 14953170154291: SINGLE USE BIOPSY VALVE MAJ-1218
• 14953170152433: SINGLE USE BIOPSY VALVE MAJ-210