VISERA HYSTEROVIDEOSCOPE

GUDID 04953170340185

HYF-V Flexible Video Hysteroscope

OLYMPUS MEDICAL SYSTEMS CORP.

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• Primary Device ID: 04953170340185
• NIH Device Record Key: 3588d2f0-a58c-4e0f-934c-a688c377758d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISERA HYSTEROVIDEOSCOPE
• Version Model Number: OLYMPUS HYF TYPE V
• 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: false
• Serial Number: true
• 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	04953170340185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022445
• Premarket Notification: K221557

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

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

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

[04953170340185]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [VISERA HYSTEROVIDEOSCOPE]

• 04953170340185: HYF-V Flexible Video Hysteroscope
• 04953170411564: VISERA HYSTEROVIDEOSCOPE
• 04953170458439: OLYMPUS HYF TYPE V