OES HYSTEROFIBERSCOPE

GUDID 04953170411571

OES HYSTEROFIBERSCOPE

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible fibreoptic hysteroscope

• Primary Device ID: 04953170411571
• NIH Device Record Key: 64b1df34-bcd0-418c-85c2-3034f7a736ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OES HYSTEROFIBERSCOPE
• Version Model Number: OLYMPUS HYF TYPE XP
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170411571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K891451

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

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

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

[04953170411571]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-12-15
• Device Publish Date: 2019-07-29

On-Brand Devices [OES HYSTEROFIBERSCOPE]

• 04953170307089: OLYMPUS HYF TYPE 1T
• 04953170058219: OLYMPUS HYF TYPE XP
• 04953170051128: HYF-1T HYS-Fiberscope 4.9mm dia w/chan
• 04953170411571: OES HYSTEROFIBERSCOPE