VISERA HYSTEROVIDEOSCOPE N6007440

GUDID 04953170458439

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video hysteroscope

• Primary Device ID: 04953170458439
• NIH Device Record Key: 87a110e1-722c-46b9-a8be-4191b1a81672
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISERA HYSTEROVIDEOSCOPE
• Version Model Number: OLYMPUS HYF TYPE V
• Catalog Number: N6007440
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170458439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221557

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

[04953170458439]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-09
• Device Publish Date: 2023-08-01

On-Brand Devices [VISERA HYSTEROVIDEOSCOPE]

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