OES URETERO-RENO FIBERSCOPE

GUDID 04953170316593

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible fibreoptic ureterorenoscope

• Primary Device ID: 04953170316593
• NIH Device Record Key: 7cb97c56-5114-4938-8d7c-867616243935
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OES URETERO-RENO FIBERSCOPE
• Version Model Number: OLYMPUS URF TYPE P5
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170316593 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912120

FDA Product Code

• FBN: Choledochoscope and accessories, flexible/rigid

Sterilization

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

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

Ethylene Oxide;High-level Disinfectant

[04953170316593]

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: 2017-10-06

On-Brand Devices [OES URETERO-RENO FIBERSCOPE]

• 04953170340307: "URF-P5 Flex Uretero Fiberscope"
• 04953170316593: OLYMPUS URF TYPE P5
• 04953170286988: OLYMPUS URF TYPE P5