OES CHOLEDOCHOFIBERSCOPE

GUDID 04953170340154

CHF-CB30L TRANSLAPAROSCOPIC CH OLEDOCHOS

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope Flexible fibreoptic choledochoscope

• Primary Device ID: 04953170340154
• NIH Device Record Key: 42a69ca2-0523-437b-8c65-f20520adb523
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OES CHOLEDOCHOFIBERSCOPE
• Version Model Number: OLYMPUS CHF TYPE CB30L
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170340154 [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

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

[04953170340154]

High-level Disinfectant;Ethylene Oxide

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 [OES CHOLEDOCHOFIBERSCOPE]

• 04953170340154: CHF-CB30L TRANSLAPAROSCOPIC CH OLEDOCHOS
• 04953170058950: OLYMPUS CHF TYPE CB30L