VISERA HYSTEROVIDEOSCOPE N6007440

GUDID 04953170458439

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope 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