Biopsy Valve

GUDID 04953170062209

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic procedure air/water valve, reusable

• Primary Device ID: 04953170062209
• NIH Device Record Key: 762b1149-4e8f-47ef-a669-1bfdfdb4ed5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biopsy Valve
• Version Model Number: MAJ-853
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170062209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021886

FDA Product Code

• FDS: Gastroscope and accessories, flexible/rigid
• ODG: Endoscopic Ultrasound System, Gastroenterology-Urology

Sterilization

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

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170062209]

High-level Disinfectant;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2018-10-08
• Device Publish Date: 2017-10-06

On-Brand Devices [Biopsy Valve]

• 04953170062209: MAJ-853
• 84953170064117: MD-495
• 84953170063943: MB-358
• 04953170438158: MB-292