RHINO-LARYNGOFIBERSCOPE

GUDID 04953170050992

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible fibreoptic nasopharyngolaryngoscope

• Primary Device ID: 04953170050992
• NIH Device Record Key: 2985c4f3-8af5-45ae-933e-855bd5f37f35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RHINO-LARYNGOFIBERSCOPE
• Version Model Number: OLYMPUS ENF-T3
• 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	04953170050992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011869

FDA Product Code

• EOB: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Sterilization

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

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

Ethylene Oxide;High-level Disinfectant

[04953170050992]

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 [RHINO-LARYNGOFIBERSCOPE]

• 04953170318214: OLYMPUS ENF-T3
• 04953170318191: OLYMPUS ENF TYPE GP
• 04953170307188: RHINO-LARYNGOFIBERSCOPE
• 04953170050992: OLYMPUS ENF-T3
• 04953170411069: RHINO-LARYNGOFIBERSCOPE
• 04953170411052: RHINO-LARYNGOFIBERSCOPE
• 04953170458293: OLYMPUS ENF TYPE XP